BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2093639 · Received May 12, 2011

    Report

    Report Number
    3004209178-2011-03482
    Event Type
    Injury
    Date Received
    May 12, 2011
    Report Date
    April 14, 2011
    Manufacturer
    MEDTRONIC 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 THE PATIENT EXPERIENCED BRUISING AND TENDERNESS AT THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET SITE FOLLOWING IMPLANT. IT WAS NOTED THAT HEALING WAS GENERALLY 6-8 WEEKS. THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS. THE SYMPTOMS WERE ASSOCIATED WITH MOVEMENT AND IT WAS NOTED THAT THE BATTERY MIGRATED OUT OF THE POCKET. CONSERVATIVE TREATMENT WAS PERFORMED FOR SEVERAL WEEKS, BUT WAS UNSUCCESSFUL. THEN THE PATIENT UNDERWENT REVISION OF THE POCKET. FOLLOWING REVISION, THE PATIENT WAS PAIN FREE. IT WAS NOTED THAT THE THERAPY WAS "SO-SO OR BETTER".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD: MODEL 3093, LOT# V575548| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD116918N