BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1840766 · Received September 17, 2010

    Report

    Report Number
    3004209178-2010-07086
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 17, 2010
    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
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PT HAD LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED LOSS OF BLADDER CONTROL AND PAIN FROM THE IMPLANTABLE NEURO STIMULATOR (INS) LOCATION DOWN TO PT'S RECTUM. THE PT HAD SPORADIC PULSES. PT STATED SHE WAS IN A CAR ACCIDENT JULY 3RD. PT HAD BRUISING OVER THE INS LOCATION. IT WAS NOTED THE HOSPITAL DID X-RAYS AND SAID THERE WAS NO BREAK. PT WAS TOLD SINCE SHE HAD SWELLING TO WAIT A COUPLE WEEKS AND SEE WHAT HAPPENS. PT STATED SHE WAITED A COUPLE WEEKS AND STILL HAD PAIN AT THE INS LOCATION AND THAT DEVICE WAS NOT HELPING WITH THE SYMPTOMS. PT WAS AT HOME AND IN FAIR CONDITION. IT WAS LATER REPORTED COMPANY REP LOOKED OVER IMPEDANCES AND NOTED IT LOOKED LIKE THE PT HAD A FRACTURE IN THE LEAD. THE PT NEEDED TO MAKE AN APPOINTMENT FOR REVISION. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADDITIONAL INFO WAS REQUESTED AND WILL BE PROVIDED WHEN AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR LEAD: MODEL 3093, LOT# V280396| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD089488N| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 3095, LOT# NAH043198V| EXPLANTED:| EXPLANTED:| IMPLANTED: