BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2827761 · Received November 9, 2012

    Report

    Report Number
    3004209178-2012-10111
    Event Type
    Injury
    Date Received
    November 9, 2012
    Report Date
    October 14, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V244042, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). ANALYSIS OF THE DEVICE, SERIAL # (B)(4), FOUND THAT THE DEVICE WAS FUNCTIONALLY OKAY WITH NO ISSUES WHEN PRESSING ON THE DEVICE. NO SIGNIFICANT ANOMALIES WERE FOUND. ANALYSIS OF THE LEAD, LOT # V244042, FOUND THAT A CONDUCTOR WAS CRUSHED IN THE LEAD BODY. CONTINUITY WAS ACCEPTABLE ON ALL CIRCUITS AND THERE WERE NO SHORTS, NO SIGNIFICANT ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR DEVICE EXPLANTED. THERE WAS NO THERAPEUTIC BENEFIT AND THERE WAS NOT NORMAL BATTERY DEPLETION. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE 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