The Duarta has been out for nearly 5 years and there has not one single piece that causes any problem. They had the meeting yesterday morning and the boss confirms the business is going very well. The haters on this board have to be people from Medtronics or the ex employees. If anyone wants to invest in the pace maker sector, St. Jude is still the best breed among everyone.
ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD Back to Search Results Model Number 7120/65 Device Problems Break; High capture threshold Event Date 01/13/2012 Event Type Injury Patient Outcome Required Intervention Manufacturer Narrative Analysis was normal. No anomaly was found.
Manufacturer Narrative All information provided by manufacturer, no medwatch form was received. Device evaluation anticipated but not yet begun.
Event Description It was reported that high threshold was observed. Suspected insulation break. The lead was explanted.
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Brand Name DURATA STS OPTIM ACTIVE FIXATION Type of Device DEFIBRILLATION LEAD Manufacturer (Section F) ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 15900 Valley View Court Na Sylmar CA 91342 Manufacturer (Section D) ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 15900 Valley View Court Na Sylmar CA 91342 Manufacturer (Section G) ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 15900 Valley View Court Na Sylmar CA 91342 Manufacturer Contact Noemi Schambach 15900 Valley View Court Na Sylmar , CA 91342 (408) 522 -6774 Device Event Key 2510422 MDR Report Key 2486693 Event Key 2383466 Report Number 2017865-2012-01910 Device Sequence Number 1 Product Code NVY Report Source Manufacturer Source Type User facility,Company Representative Reporter Occupation Other Health Care Professional Type of Report Followup,Initial 1 Device Was Involved in the Event 1 Patient Was Involved in the Event Date FDA Received 03/10/2012 Is This An Adverse Event Report? Yes Is This A Product Problem Report? Yes Device Operator Other Health Care Professional Device EXPIRATION Date 05/31/2014 Device MODEL Number 7120/65 Device Catalogue Number SMTFY999 Was Device Available For Evaluation? Device Returned To Manufacturer Date Returned to Manufacturer 01/31/2012 Is The Reporter A Health Professional? Yes Was the Report Sent to FDA? No Distributor Facility Aware Date 01/13/2012 Device Age 7 mo Event Location Hospital Was The Report Sent To Manufacturer? No Date Manufacturer Received 01/20/2012 Was Device Evaluated By Manufacturer? Yes Date Device Manufactured 05/31/2011 Is The Device Single Use? Yes Is this a Reprocessed and Reused Single-Use Device? No Is the Device an Implant? No Is this an Explanted Device? Type of Device Usage Initial