BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2052549 · Received April 11, 2011

    Report

    Report Number
    3004209178-2011-02720
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 31, 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
    OK, US
    Reporter Occupation
    PHYSICIAN

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT AN EXPLANT PROCEDURE, THE LEAD BROKE DURING REMOVAL. SPECIFICALLY, 4 CONTACTS ON ONE LEAD AND 3 CONTACTS ON THE OTHER LEAD REMAINED IN THE PT. THE PT WAS HAVING THE NEUROSTIMULATOR SYSTEM REMOVED BECAUSE THEY NEEDED TO HAVE AN MRI OF THE SPINE. ADDITIONAL INFO WAS REQUESTED. SEE ALSO MFR REPORT #3004209178-2011-02721.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention EXPLANTED:| LEAD: MODEL 3093, LOT # J0340317V| EXPLANTED:| IMPLANTED:| IMPLANTED:| LOT # NBV122131H| IMPLANTABLE PULSE GENERATOR: MODEL 3023,| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 3095, LOT # NAH016609V| PROGRAMMER: MODEL 3031A, LOT # NGM012356P| LEAD: MODEL 3093, LOT # J0443911V| EXTENSION: MODEL 3095, LOT # NAH016780V| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3031A, LOT # NGM016040P