BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2083019 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-03272
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 3, 2009
    Report Date
    April 14, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE IMPLANT OF THE IMPLANTABLE NEUROSTIMULATOR (INS), THE POCKET HAD BEEN CREATING A LOT OF PAIN REGARDLESS OF WHETHER THE SIMULATION WAS ON OR OFF. IT WAS NOTED THAT THE PT HAD LOST A LOT OF WEIGHT. THE CAUSE OF THE EVENT WAS PAIN OVER BATTERY INSERTION SITE. CONSERVATIVE TREATMENT FAILED SO THE BATTERY AND LEAD WERE EXPLANTED. IT WAS NOTED THAT THE PT NEVER ACHIEVED THERAPEUTIC EFFECT OF 50% OR BETTER REDUCTION IN SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD72768N| LEAD: MODEL 3093, LOT# V192314