BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2030146 · Received March 7, 2011

    Report

    Report Number
    3004209178-2011-01676
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE LEAD WOULD NOT PASS THE SET SCREW IN THE CONNECTOR BLOCK OF THE NEUROSTIMULATOR. AFTER MULTIPLE INSERTION ATTEMPTS, THE PHYSICIAN USED A NEW DEVICE. NO INJURIES WERE REPORTED AND THE PATIENT RECOVERED WITHOUT SEQUELAE.

    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 74 YR STIM ACCESSORY: MODEL WRENCH, LOT# UNK