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<p>[QUOTE="Anonymous, post: 4067656"]Abstract: P1838</p><p>Riata lead failure; A report from Northern Ireland Riata lead screening programme</p><p>Authors:</p><p>V. Kodoth1, N. Cromie1, E. Lau1, D. McEneaney2, C. Wilson1, M.J. Roberts1, 1Royal Victoria Hospital - Belfast - United Kingdom, 2Craigavon Area Hospital, Craigavon Cardiac Centre - Craighavon - United Kingdom,</p><p><br /></p><p>Topic(s):</p><p>Automatic implantable cardioverter / defibrillator</p><p>Citation: </p><p>European Heart Journal ( 2011 ) 32 ( Abstract Supplement ), 310</p><p>The st: Jude Medical Riata family of leads (1560,-61,-62,-70,-71,-72,-80,-81,-82,-90,-91,-92,7000,-01,-02,-10,-11,-12,-40,-41,-42,-50,-51,-52,-20,-21,-22,-70,-71,-30,-31) are high voltage implantable cardioverter defibrillator (ICD) leads. Insulation related inappropriate shocks were noted in a patient in Northern Ireland in November 2006. Lead insulation breach was from internal lumen to external surface. The frequency of lead malfunction in Northern Ireland appeared to exceed the manufacturer quoted values. Active surveillance of all patients with a Riata lead in Northern Ireland was commenced in August 2010. On 16/12/2010 the U.K MHRA issued a medical device alert for Riata and Riata-ST leads. The objectives of the Northern Ireland Riata lead screening programme were to identify insulation defects, risk factors, define prevalence, determine management plan for lead defects, and develop a follow up programme and additional lead screening projects.</p><p><br /></p><p>Methods: All patients with Riata/Riata-ST and Riata Optim leads in Northern Ireland were invited for screening with high resolution fluoroscopic images at 15fps and ICD lead parameters were checked. Fluoroscopic images were read by two cardiologist blinded to the patient data and insulation breach was identified as negative, positive or borderline.</p><p><br /></p><p>Results: Two hundred and twelve patients had a Riata lead implanted in Northern Ireland. Of these, 164 were males and 48 females. Mean age at the time of implantation was 62.7±13.40 years. Lead model 1580 was implanted in 16 patients, 1582 in 69, 1570 in 8, 1572 in 5, 7000 in 60, 7002 in 41, 1571 in 2, 1742 in 2, 7040 in 6 and 7022 in 3 patients. One hundred and sixty five out of 212 patients were screened as 28 were dead, 5 had the lead explanted prior screening, 3 patients were excluded and 11 did not attend the screening programme. Mean screening period after implantation was 3.98±1.43 years. After screening 25 (15%) patients were classified as positive, 3 (1.8%) borderline and 137 (83%) negative for insulation breach. Five (3%) out of the 25 patients presented with spontaneous lead issues and 20 (12%) were identified by fluoroscopy. Seven (25%) patients had the defective lead removed. The rest of the patients are closely monitored with surveillance (fluoroscopy and ICD parameter check) every 3 months.</p><p><br /></p><p>Conclusion: A significant proportion (15%) of patients with Riata and Riata-ST leads had an insulation breach on screening. Clinically significant events was noted in 20% of patients. Further surveillance plans for negative and borderline category need to be developed and agreed internationally.[/QUOTE]</p><p><br /></p>
[QUOTE="Anonymous, post: 4067656"]Abstract: P1838 Riata lead failure; A report from Northern Ireland Riata lead screening programme Authors: V. Kodoth1, N. Cromie1, E. Lau1, D. McEneaney2, C. Wilson1, M.J. Roberts1, 1Royal Victoria Hospital - Belfast - United Kingdom, 2Craigavon Area Hospital, Craigavon Cardiac Centre - Craighavon - United Kingdom, Topic(s): Automatic implantable cardioverter / defibrillator Citation: European Heart Journal ( 2011 ) 32 ( Abstract Supplement ), 310 The st: Jude Medical Riata family of leads (1560,-61,-62,-70,-71,-72,-80,-81,-82,-90,-91,-92,7000,-01,-02,-10,-11,-12,-40,-41,-42,-50,-51,-52,-20,-21,-22,-70,-71,-30,-31) are high voltage implantable cardioverter defibrillator (ICD) leads. Insulation related inappropriate shocks were noted in a patient in Northern Ireland in November 2006. Lead insulation breach was from internal lumen to external surface. The frequency of lead malfunction in Northern Ireland appeared to exceed the manufacturer quoted values. Active surveillance of all patients with a Riata lead in Northern Ireland was commenced in August 2010. On 16/12/2010 the U.K MHRA issued a medical device alert for Riata and Riata-ST leads. The objectives of the Northern Ireland Riata lead screening programme were to identify insulation defects, risk factors, define prevalence, determine management plan for lead defects, and develop a follow up programme and additional lead screening projects. Methods: All patients with Riata/Riata-ST and Riata Optim leads in Northern Ireland were invited for screening with high resolution fluoroscopic images at 15fps and ICD lead parameters were checked. Fluoroscopic images were read by two cardiologist blinded to the patient data and insulation breach was identified as negative, positive or borderline. Results: Two hundred and twelve patients had a Riata lead implanted in Northern Ireland. Of these, 164 were males and 48 females. Mean age at the time of implantation was 62.7±13.40 years. Lead model 1580 was implanted in 16 patients, 1582 in 69, 1570 in 8, 1572 in 5, 7000 in 60, 7002 in 41, 1571 in 2, 1742 in 2, 7040 in 6 and 7022 in 3 patients. One hundred and sixty five out of 212 patients were screened as 28 were dead, 5 had the lead explanted prior screening, 3 patients were excluded and 11 did not attend the screening programme. Mean screening period after implantation was 3.98±1.43 years. After screening 25 (15%) patients were classified as positive, 3 (1.8%) borderline and 137 (83%) negative for insulation breach. Five (3%) out of the 25 patients presented with spontaneous lead issues and 20 (12%) were identified by fluoroscopy. Seven (25%) patients had the defective lead removed. The rest of the patients are closely monitored with surveillance (fluoroscopy and ICD parameter check) every 3 months. Conclusion: A significant proportion (15%) of patients with Riata and Riata-ST leads had an insulation breach on screening. Clinically significant events was noted in 20% of patients. Further surveillance plans for negative and borderline category need to be developed and agreed internationally.[/QUOTE]
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Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Medical Equipment/Device Sales
>
St Jude Medical
>
Riata 15% Insulation Breach Rate
>
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Medical Equipment/Device Sales
>
St Jude Medical
>
Riata 15% Insulation Breach Rate
>