BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN INTERSTIM

    MDR report key: 2230567 · Received August 12, 2011

    Report

    Report Number
    3007566237-2011-06310
    Event Type
    Injury
    Date Received
    August 12, 2011
    Report Date
    July 19, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, "UNRETRIEVED DEVICE FRAGMENTS MODELS 3093 AND 3889 INTERSTIM TINED LEADS", (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS DAMAGED DURING AN EXPLANT PROCEDURE. THE PHYSICIAN INDICATED THE LEAD HAD FRAYED AND A PORTION OF THE LEAD WAS LEFT IN THE PT'S BODY. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN INTERSTIM EZW MEDTRONIC NEUROMODULATION IPG URO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXPLANTED:| LEAD: MODEL 3889, LOT # UNK