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St. Jude Medical Inc. Message Board

  • stocker4949 stocker4949 Apr 20, 2012 12:07 PM Flag

    Spoke with St. Jude ppl last night

    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.

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    • Maude Database has a lot of Durata Failure info....Wake up...

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      MAUDE Adverse Event Report: ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISIONDURATA STS OPTIM ACTIVE FIXATIONDEFIBRILLATION LEAD

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      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.


      Search Alerts/Recalls

      New Search | Submit an Adverse Event Report

      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

 
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