BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2424022 · Received January 20, 2012

    Report

    Report Number
    3004209178-2012-00400
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Report Date
    January 2, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT PROGRAMMER: MODEL 3037, SERIAL # (B)(4), IMPLANTED: NA, EXPLANTED: NA. LEAD: MODEL 3889, LOT # V182143, IMPLANTED: 2009 (B)(6), EXPLANTED: UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT NEVER HAD THERAPEUTIC EFFECT. FOR THE FIRST 3 MONTHS AFTER IMPLANT, THE PATIENT HAD ANOTHER BLADDER SURGERY/PROCEDURE, WHICH PROVIDED SYMPTOM CONTROL. ALSO, THERE WAS AN OVERSTIMULATION SENSATION WHEN THE PATIENT INCREASED STIMULATION. THE PATIENT FELL AND BROKE HER HIP ON THE SAME SIDE AS THE IMPLANT AND THEN BROKE THE OTHER HIP. REPROGRAMMING WAS SUGGESTED TO ADDRESS STIMULATION NEEDS. THE PATIENT WANTED THE DEVICE REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1