BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1120757 · Received August 15, 2008

    Report

    Report Number
    3004209178-2008-05010
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 17, 2008
    Manufacturer
    MPROC, JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT ARRIVED AT A HOSP WITH A SERIOUS INFECTION. IT WAS DIAGNOSED AS SEPSIS. THE PHYSICIAN EXPLANTED THE IPG AND TRIED TO EXPLANT THE LEADS. THE LEADS TORE. A FUTURE PROCEDURE WAS SCHEDULED TO EXPLANT THE REMAINING PARTS OF THE LEADS. FURTHER INFO IS BEING REQUESTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MPROC, JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| LEAD M2ODEL LEAD| IMPLANTED