BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2622388 · Received June 20, 2012

    Report

    Report Number
    3004209178-2012-04665
    Event Type
    Malfunction
    Date Received
    June 20, 2012
    Report Date
    May 23, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V242434, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND NO STIMULATION SENSATION FROM THE IMPLANTABLE NEUROSTIMULATOR (INS) SINCE A FUSION SURGERY ON HER BACK 6 MONTHS PRIOR. THE PATIENT PROGRAMMER WOULD NOT COMMUNICATE WITH OR WITHOUT THE ANTENNA. TROUBLESHOOTING WAS PERFORMED AND THE PROGRAMMER STILL WOULD NOT COMMUNICATE WITH THE INS. THE PATIENT REPORTED NOT BEING TRAINED ON USING THE DEVICE AND HAD NEVER CHANGED BATTERIES IN THE PROGRAMMER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT FELT STIMULATION FOR THE FIRST YEAR AND A HALF. COMMUNICATION BETWEEN THE PROGRAMMER AND INS WAS ALSO NOT POSSIBLE WHEN ATTEMPTED BY THE PHYSICIAN APPROXIMATELY ONE MONTH PRIOR. THE PATIENT WAS HOSPITALIZED FOR TREATMENT OF DEPRESSION. THE PATIENT WAS CURRENTLY NOT FEELING STIMULATION AND SHE COULD NOT USE THE PATIENT PROGRAMMER. 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 MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1