BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1926419 · Received November 11, 2010

    Report

    Report Number
    3004209178-2010-09365
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 27, 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
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT NEVER EXPERIENCED A THERAPEUTIC EFFECT FROM HER IMPLANTABLE NEUROSTIMULATOR. HER DEVICE WAS REPROGRAMMED AND SHE EXPERIENCED "A STABBING SHOCKING SENSATION" WITH STIMULATION SET AT 1.8V. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 74 YR EXPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD112386N| EXPLANTED:| LEAD: MODEL 3093, LOT# V503941