BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2809835 · Received October 31, 2012

    Report

    Report Number
    3004209178-2012-09747
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    August 21, 2012
    Report Date
    October 3, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-33, LOT# V941222, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT PLAYED GOLF FOR THE FIRST TIME AFTER IMPLANT, THE FIRST 8 HOLES WERE WONDERFUL, BUT AFTER 8 HOLES THE PATIENT TOOK A LIGHT SWING TO HIT A SHORT SHOT AND GOT IMMEDIATE PAIN AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE. THE PATIENT DESCRIBED THE PAIN AS LIKE WHAT HAPPENS AFTER BUMPING INTO SOMETHING, LIKE A "BRUISED PAIN". THE PATIENT WAS DESCRIBED AS "DEEP" PAIN ALL AROUND THE INS. IT WAS REPORT THAT WHEN SHE PRESSED ON THE TOP END OF THE INS IT WAS VERY SORE. THE PATIENT DECLINED TURNING OFF THE INS UNTIL IT COULD BE CHECKED BECAUSE SHE DID NOT BELIEVE THE PAIN WAS STIMULATION RELATED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANT WAS REMOVED (B)(6) 2012. NO PATIENT OUTCOME WAS REPORTED.

    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 78 YR Required Intervention