BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL SDX

    MDR report key: 1896545 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05009
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 1, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE PROXIMAL INSULATION WAS ABRADED AT 9 CM TO 9.5 CM FROM THE CONNECTOR PIN, DUE TO FRICTION WITH ANOTHER DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED HIGH THRESHOLDS AND LOSS OF CAPTURE. THE LEAD WAS REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2004. THE PATIENT EXPERIENCED DISCOMFORT IN THE LOWER LEFT SIDE AND CONSTIPATION SINCE SURGERY. IN 2008, A PHYSICIAN FROM A PAIN CLINIC PRESCRIBED PAIN MEDICATION AND GAVE INJECTIONS FOR THE INTERMITTENT PAIN CONCERNS. A CT SCAN WAS DONE IN 2008 BUT "DID NOT SHOW WHAT THE ISSUE WAS, JUST SOME MINOR TISSUE PROBLEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1688TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention