BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2830496 · Received November 13, 2012

    Report

    Report Number
    3004209178-2012-10201
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POWER ON RESET (POR) CONDITION. IT WAS NOTED THAT THE POR WAS "FOUND IMMEDIATELY POST -IMPLANT." IT WAS NOTED THAT "IT WAS SUSPECTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS HIT BY CAUTERY DURING THE IMPLANT." IT WAS NOTED THAT THE DEVICE WAS INTERROGATED WITH THE CLINICIAN PROGRAMMER AND "THIS WAS DONE SUCCESSFULLY." ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP REPORTED THE DEVICE DID NOT HAVE AN ERROR CODE BUT IT WAS KNOWN THE PROBLEM WAS FROM THE CAUTERY AS THE HEALTH CARE PROVIDER LEFT THE DEVICE INSIDE THE PATIENT WHEN THEY WERE ENLARGING THE POCKET. THE POWER ON RESET (POR) WAS CLEARED AND NO OTHER PROBLEMS WERE NOTED AND THE PATIENT LEFT THE SURGERY CENTER THAT DAY WITH A POSITIVE OUTCOME.

    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