BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1843560 · Received September 22, 2010

    Report

    Report Number
    3004209178-2010-07194
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    November 1, 2009
    Report Date
    August 25, 2010
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2010, THAT THE PT WAS UNABLE TO ADJUST THE STIMULATION. THE PT HAD PAIN IN THE "TAILBONE" PRIOR TO THE DEVICE IMPLANT, BUT THE PAIN BECAME WORSE FOLLOWING THE IMPLANT. THE STIMULATION WAS SET AT 2.0 VOLTS ON PROGRAM 3. ADDITIONAL INFORMATION WAS LATER REC'D STATING THAT THE PT'S DEVICE WAS REPROGRAMMED SUCCESSFULLY AND THE PT NO LONGER HAD PROBLEMS WITH THE DEVICE SYSTEM. IT WAS LATER REPORTED ON (B)(6) 2010, THAT THE PT HAD PAIN IN THE SACRAL AREA FOLLOWING THE IMPLANTATION OF THE DEVICE. THERE WAS NO KNOWN RELATED INCIDENT OR ACCIDENT REPORTED. THE PT "ALWAYS HAD ISSUES WITH THE LUMBAR PART OF THE BACK BUT NOT THE SACRAL PART." IT WAS NOTED THAT THE STIMULATION WAS HELPING THE PT'S BLADDER CONDITION. IT WAS LATER REPORTED THAT THE PT NEVER REC'D GOOD STIMULATION THERAPY FROM THE IMPLANTED DEVICE. THE LEAD LOCATION APPEARED TO BE AT S4 INSTEAD OF S3. THE LEAD POSITION ENDED UP AGAINST THE WALL OF THAT FORAMEN, THEN TURNED OUT TOWARD THE MIDLINE OF THAT FORAMEN. THE PT REC'D STIMULATION IN THE WRONG LOCATION. THE PT FELT STIMULATION MOSTLY IN THE TAILBONE AREA. THE PT'S LEAD WAS MOVED THE WEEK PRIOR TO THIS REPORT. THE PT WAS THEN RECEIVING GOOD THERAPEUTIC BENEFIT. NO FURTHER DETAILS OR PT OUTCOME WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT REC'D AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AFTER FURTHER REVIEW, IT WAS REPORTED THE REPRESENTATIVE REPORTS THAT THE PATIENT HAD GOOD STIMULATION TRIAL BUT THE PERMANENT IMPLANT NEVER GAVE HER GOOD STIMULATION RELIEF. ADDITIONAL INFORMATION REPORTS THAT THE PATIENT SAID ANOTHER TIME THE DEVICE BROKE AND HAD TO BE REPLACED. THE PATIENT SAID THIS WAS ABOUT 4 YEARS AGO/ABOUT A YEAR AFTER IMPLANT, THE PATIENT SAID THE LEADS MOVED AND THEY HAVE TO PUT IN A WHOLE NEW IMPLANT. THE PATIENT SAID THEY PUT IT DEEPER IN THE MUSCLE TISSUE. THE PATIENT SAID WHEN THE DEVICE "BROKE" HE HAS TERRIBLE PAIN IN HER TAILBONE.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention EXPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD095064N| LEAD: MODEL 3093, LOT# V335182| EXPLANTED: