BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3141074 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08496
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 10, 2013
    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# VA03N2K, IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE MONTH AFTER THE PATIENT HAD THE DEVICE IMPLANTED, SHE WAS IN A CAR ACCIDENT AND WAS HIT FROM BEHIND. THE PATIENT NEEDED TO GET SCREWS IN HER CERVICAL FUSION AREA CHECKED TO MAKE SURE THEY WERE NOT MOVED. COMPATIBILITY GUIDELINES FOR MRI, CT/CAT SCANS AND X-RAY AND/OR FLUORO WERE REQUESTED. IT WAS NOTED THAT THE PATIENT WAS UPSET THAT SHE COULD NOT GET AN MRI AND INDICATED SHE WOULD HAVE THE DEVICE TAKEN OUT. THE PATIENT HAD PROBLEMS WITH HER EXTREMITIES, NUMBNESS AND TINGLING DUE TO NECK FUSION. THE PATIENT INDICATED THAT HER DOCTOR DID NOT KNOW WHY THIS WAS HAPPENING AND BECAUSE OF THE ISSUES, THE PATIENT DID NOT WORK. 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
    243000 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention