BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM NEUROSTIMULATOR, UNKNOWN

    MDR report key: 3854289 · Received June 6, 2014

    Report

    Report Number
    3007566237-2014-01561
    Event Type
    Injury
    Date Received
    June 6, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS STATED THAT THE REPORTER WAS IN THE HOSPITAL WITH 4 OTHER PATIENTS WITH DEFECTIVE PACERS BUT THEY COULDN¿T NAME THE PATIENTS. REFER TO MANUFACTURER REPORTS # 3007566237-2014-01558, 3007566237-2014-01559, AND 3007566237-2014-01560 FOR FIRST, SECOND, AND THIRD DEFECTIVE PACERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333132 INTERSTIM NEUROSTIMULATOR, UNKNOWN STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization