BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2673714 · Received July 30, 2012

    Report

    Report Number
    3004209178-2012-06214
    Event Type
    Injury
    Date Received
    July 30, 2012
    Report Date
    June 29, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT # V952169, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN A MOTOR VEHICLE ACCIDENT IN WHICH CAUSED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) TO BE "COMPROMISED." IT WAS ALSO REPORTED THAT THERE WAS A POSSIBLE INFECTION ASSOCIATED WITH THE INS. THE INS WAS SUBSEQUENTLY REPLACED BUT THE SAME LEAD COMPONENT WAS LEFT IN PLACE FOR CONTINUED THERAPY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention