BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2182196 · Received July 7, 2011

    Report

    Report Number
    3004209178-2011-05160
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 13, 2011
    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
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT'S IMPLANTABLE NEUROSTIMULATOR "WASN'T WORKING RIGHT" AND HAD BEEN TURNED OFF FOR ALMOST 3 YEARS. HER HEALTH CARE PROFESSIONAL (HCP) CHECKED THE SYSTEM AND FOUND THAT ONE OF THE LEADS WAS NOT WORKING. THE HCP "CHANGED THE LEADS" AND THE PT FELT LIKE SHE WAS BEING "ELECTROCUTED." AN X-RAY WAS TAKEN AND EVERYTHING LOOKED FINE. THE HCP RECOMMENDED THAT THE SYSTEM BE EXPLANTED BECAUSE IT WAS NOT WORKING. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES 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 26 YR EXPLANTED:| PROGRAMMER: MODEL 3031A, LOT# NGM005310P| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 3095, LOT# NAH030462V| EXPLANTED:| LEAD: MODEL 3889, LOT# V007432