BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2210314 · Received August 9, 2011

    Report

    Report Number
    3004209178-2011-06198
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 15, 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). THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, "UNRETRIEVED DEVICE FRAGMENTS MODELS 3093 AND 3889 INTERSTIM TINED LEADS", EDUCATIONAL BRIEF/PHYSICIAN COMMUNICATION ((B)(6) 2010). 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 THE NEUROSTIMULATION SYSTEM WAS EXPLANTED SO THAT THE PATIENT COULD HAVE AN MRI. DURING EXPLANT, THE LEAD BROKE AND THE DISTAL END OF THE LEAD INCLUDING THE TINES AND ELECTRODES WERE LEFT IMPLANTED. THE SYSTEM WAS NOT REPLACED.

    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 60 YR Required Intervention EXPLANTED:| PROGRAMMER: MODEL 3037, LOT # NJD082485N| IMPLANTED:| LEAD: MODEL 3093, LOT # V208207