BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1915081 · Received December 1, 2010

    Report

    Report Number
    3004209178-2010-10092
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 23, 2010
    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
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD AN INFECTION POST IMPLANT AND WAS ON ANTIBIOTICS INTERMITTENTLY SINCE THE DEVICE WAS IMPLANTED. HE HAD THREE "SORES/HOLES" (ONE IN BACK AND TWO OVER THE DEVICE) AND IT WAS NOTED THAT HE COULD SEE PART OF THE DEVICE. THE "HOLES" WERE PAINFUL AND HAD "STUFF" COMING OUT OF THEM, REQUIRING THAT THE PT CHANGE THE BANDAGES DAILY. HE ALSO EXPERIENCED A SHOCKING/JOLTING SENSATION EVERY ONCE IN A WHILE BUT NOTED THAT HIS DEVICE WAS WORKING WELL. HIS PRIMARY CARE DOCTOR WAS TRYING TO FIND A SURGEON TO EXPLANT THE DEVICE. ADDITIONAL INFO WAS REQUESTED.

    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 45 YR Required Intervention IMPLANTED:| EXTENSION: MODEL 3095, LOT# NAH011069V| LEAD: MODEL 3889, LOT# J0343951V| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3031A, LOT# NGM010566P| EXPLANTED: