BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2630464 · Received June 27, 2012

    Report

    Report Number
    3004209178-2012-04880
    Event Type
    Malfunction
    Date Received
    June 27, 2012
    Report Date
    May 29, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# V875334, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRUISING IN THE TAILBONE AREA, AS WELL AS PAIN, SWELLING, AND NUMBNESS IN BOTH LEGS. HER ANKLES AND FEET WERE SWOLLEN. SINCE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF, THE PAIN WAS LESS, BUT STILL PRESENT. THE SWELLING HAD DECREASED WHILE HER LEGS WERE STILL ELEVATED. THE PATIENT WAS ON A GENERIC BRAND OF VICODIN/ACETAMINOPHEN FOR POST-SURGICAL PAIN. A SHOCKING/JOLTING SENSATION WAS ALSO REPORTED. THE INS VOLTAGE WAS TOO STRONG AND SHE GOT A JOLT. THE PATIENT WAS AFRAID TO TURN INS BACK ON. 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