BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2493954 · Received March 16, 2012

    Report

    Report Number
    3004209178-2012-01627
    Event Type
    Injury
    Date Received
    March 16, 2012
    Report Date
    February 22, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3093-28, LOT# V082173, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2012, PROGRAMMER: MODEL 3037, SERIAL# (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF NEUROSTIMULATOR MODEL 3058 (B)(4) SHOWED NO ANOMALIES. ANALYSIS OF LEAD MODEL 3093-28 LOT# V082173 SHOWED THAT THE CONDUCTOR IN THE LEAD BODY WAS BROKEN BETWEEN THE THIRD AND FOURTH TINES (MEASURED FROM THE DISTAL END). THE CONDUCTOR WIRES WERE CRUSHED AND TWO CONDUCTOR WIRES WERE BROKEN AT THE MOST PROXIMAL TINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION WHEN NEAR ELECTRONICS (SUCH AS MICROWAVE) AND DURING THUNDERSTORMS. IMPEDANCE MEASUREMENTS SHOWED >4000 OHMS ON ALL ELECTRODE COMBINATIONS EXCEPT C+ AND 3-. THE PATIENT UNDERWENT A SURGICAL REVISION WHERE HER IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM WAS REPLACED. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    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