BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 676263 · Received January 26, 2006

    Report

    Report Number
    MW1037835
    Event Type
    Malfunction
    Date Received
    January 26, 2006
    Date of Event
    January 24, 2006
    Manufacturer
    SJM
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SINGLE CHAMBER ICD IMPLANTED. DUE TO INCREASED CAPTURE THRESHOLD RV (4.V). PROCEDURE PERFORMED TO REPOSITION RV LEAD (ACTIVE FIXATION) TOOK 25 TURNS TO RETRACT HELIX THEN "POP" FELT. LEAD REMOVED AND INSPECTED. NO OBVIOUS DEFECT. HOWEVER, HELIX COULD NOT RE-ADVANCE WITH UP TO 30 TURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL RV PACE / SENSE / SHOCK LEAD DTB SJM 1581-65 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR