BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2714458 · Received August 24, 2012

    Report

    Report Number
    3004209178-2012-07372
    Event Type
    Malfunction
    Date Received
    August 24, 2012
    Report Date
    July 26, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# V192542, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND WAS TO HAVE HER DEVICE CHECKED OUT AT OUTPATIENT SURGERY. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD NOT BEEN FUNCTIONING FOR 9 MONTHS AND WAS UNABLE TO CONNECT WITH A PATIENT PROGRAMMER OR PHYSICIAN PROGRAMMER. IT WAS BELIEVED THAT THE INS HAD NORMAL BATTERY DEPLETION WITH A POTENTIAL OF THE LEADS HAVING DISCONNECTED FROM THE INS. ADDITIONAL INFORMATION HAD 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