BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2082990 · Received May 4, 2011

    Report

    Report Number
    3004209178-2011-03223
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    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
    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. 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 DURING AN IMPLANT PROCEDURE (BATTERY REPLACEMENT), THE IMPEDANCES WERE OUT OF RANGE WHEN THE OLD LEAD WAS CONNECTED TO THE NEW NEUROSTIMULATOR. THE PHYSICIAN INSPECTED THE LEAD PRIOR INSERTION AND THE ELECTRODES APPEARED IN GOOD CONDITION. THE PHYSICIAN THEN UNSCREWED THE SET SCREWS TO REMOVE THE LEAD. AFTER MULTIPLE ATTEMPTS AT UNSCREWING THE SET SCREW, THE LEAD FRACTURED LEAVING A FRAGMENT INSIDE THE NEUROSTIMULATOR. THE OTHER SECTION OF THE LEAD REMAINED IN THE PT. THE PROCEDURE WAS THEN ABORTED AS THERE WAS NO ADDITIONAL NEUROSTIMULATOR AVAILABLE FOR IMPLANT. THE PT WAS SUBSEQUENTLY RE-IMPLANTED WITH A NEW NEUROSTIMULATOR AND LEAD ON THE CONTRALATERAL SIDE WITHOUT INCIDENT. NO INJURIES WERE REPORTED AND THE PT RECOVERED WITHOUT SEQUELAE. IF ADDITIONAL INFO IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    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 52 YR Required Intervention EXPLANTED:| LEAD: MODEL 3886, LOT# J0123327V| IMPLANTABLE PULSE GENERATOR: MODEL 3023,| IMPLANTED:| IMPLANTED:| LOT# NBV111978H| EXPLANTED: