BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1953809 · Received January 4, 2011

    Report

    Report Number
    3007566237-2011-00014
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 2010
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD REVISION SURGERY. DURING THE PROCEDURE, IMPEDANCE MEASUREMENTS OF >4000 OHMS WERE SEEN ON SOME OF THE BIPOLAR LEAD PAIRS (THOSE WITH ELECTRODE 3). THE DEFAULT TEST VALUES WERE INCREASED AND THE IMPEDANCE TEST WAS RERUN WITH THE OUTCOME OF ALL PAIRS WERE WITHIN NORMAL LIMITS. ADD'L INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC NEUROMODULATION 3023 NA

    Patients

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