BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2240999 · Received August 17, 2011

    Report

    Report Number
    3004209178-2011-06464
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Report Date
    July 22, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND NOTED THAT SHE HAS HAD "3 OUT OF 4 LEADS BREAK" AND WAS TOLD THAT SHE ONLY HAD ONE FUNCTIONAL LEAD LEFT BY HER HEALTH CARE PROVIDER (HCP). IT WAS REPORTED THAT HER FIRST LEAD BROKE WHILE SHE WAS DOING YOGA WHEN THE FIRST LEAD BROKE AND ADDITIONAL LEADS BROKE WHILE WALKING FOR EXERCISE. FOLLOW-UP WITH HER HCP CONFIRMED HIGH IMPEDANCES OF MORE THAN 4000 OHMS WERE SEEN ON 3 OUT OF 4 ELECTRODES AND WAS ATTRIBUTED TO A FRACTURED LEAD. HER PHYSICIAN REPORTED THAT LEAD REPLACEMENT WILL BE SCHEDULED WHEN LAST LEAD BREAKS OR THERE IS A LOSS OF CLINICAL BENEFIT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| LEAD: MODEL 3889, LOT# V145015| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD076040N