BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1192083 · Received October 7, 2008

    Report

    Report Number
    3004209178-2008-06416
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 9, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP MEDWATCH REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE AND/OR WHEN ADDITIONAL INFORMATION IS RECEIVED FROM THE HCP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BUMP OVER HER SACRUM. SHE SCRATCHED IT AND IT "POPPED" RESULTING IN AVULSION OF THE LEAD. NO OBVIOUS INFECTION WAS NOTED. THE SYSTEM WAS EXPLANTED. RE-IMPLANTATION WAS PLANNED ONCE THE TISSUE HEALED. THE PATIENT OUTCOME IS UNKNOWN. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention LEAD MODEL 3889 LOT# V050376| EXPLANTED| IMPLANTED