BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2910851 · Received January 11, 2013

    Report

    Report Number
    3004209178-2013-00472
    Event Type
    Injury
    Date Received
    January 11, 2013
    Report Date
    February 28, 2011
    Manufacturer
    MDT 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28 LOT# V447412, IMPLANTED: 2010 (B)(6), EXPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (SERIAL #(B)(4)) FOUND THAT THERE WERE NO ANOMALIES. ANALYSIS OF THE LEAD (LOT#V447412) FOUND THAT THE BODY HAD BEEN BROKEN AT OR NEAR THE TINES. A SYSTEM TEST FROM THE INS TO THE BROKEN END OF THE LEAD REVEALED THAT THE OUTPUT WAS GOOD. ALL CONDUCTOR WIRES IN THE LEAD WERE BROKEN 5.2 CM FROM THE DISTAL END.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED, THERE WAS A LOSS OF EFFICACY. A "POSSIBLE LEAD FRACTURE" WAS REPORTED. THE IMPLANTABLE NEUROSTIMULATOR AND LEAD WERE EXPLANTED AND REPLACED. NORMAL BATTERY DEPLETION WAS ALSO NOTED. IT WAS STATED THE PATIENT RECOVERED WITHOUT SEQUELA. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17427 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention