BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2878272 · Received December 18, 2012

    Report

    Report Number
    3004209178-2012-11992
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 21, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V914059, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS NO STIMULATION SENSATION AND THERE WAS A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THE PATIENT FELL ON (B)(4) 2012 ON THEIR "BUTT CHEEK" WHERE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS. A COUPLE HOURS AFTER THE FALL THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO BLOATING. IT WAS NOTED A CATHETER WAS INSERTED AND PATIENT STILL HAD THE CATHETER AT THE TIME OF REPORT. PATIENT DID NOT FEEL ANY STIMULATION AND WANTED TO INCREASE IT BUT THE SCREEN WAS BLANK. BATTERIES WERE CHECKED AND APPEARED RUSTY. THE BATTERY COMPARTMENT WAS CLEANED OUT AND NEW BATTERIES WERE USED. THE PATIENT WAS ABLE TO SYNCH WITHOUT THE ANTENNA. THE LIGHTNING BOLT HAD BEEN SEEN AND STIMULATION WAS AT 1.0. IT WAS NOTED THE PATIENT WAS NORMALLY AT 4.5. PATIENT WAS UNABLE TO SYNCH AGAIN TO INCREASE STIMULATION. PATIENT KEPT GETTING POOR COMMUNICATION WITH AND WITHOUT THE ANTENNA. IT WAS NOTED THE PATIENT HAD AN APPOINT MENT SCHEDULED WITH THEIR HEALTH CARE PROVIDER. 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 00062 YR