BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3634850 · Received February 19, 2014

    Report

    Report Number
    3004209178-2014-03272
    Event Type
    Injury
    Date Received
    February 19, 2014
    Report Date
    January 30, 2014
    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

    FINAL ANALYSIS OF THE (TINED LEAD) (V368682) REVEALED ALL CONDUCTORS WERE BROKEN (OVERSTRESS DAMAGE) NEAR THE CONNECTOR WELD SITES. FINAL ANALYSIS OF THE (INTERSTIM LL) ((B)(4)) REVEALED BATTERY/NORMAL END OF LIFE/TELEMETRY AND OUTPUT OKAY.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V368682, IMPLANTED: 2009 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S ORIGINAL LEAD AND BATTERY WERE REMOVED DUE TO IMPEDANCE ISSUES ON THE LEAD AND LOW BATTERY LIFE. ADDITIONAL INFORMATION RECEIVED FOUR DAYS LATER REPORTED IMPEDANCE TESTING WAS PERFORMED (B)(6) 2014 AND ALL COMBINATIONS SHOWED OVER 4000 OHMS. IT WAS UNKNOWN IF THE IMPEDANCE ISSUE WAS THE CAUSE OF THE LOW IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY OR IF THE INS DEPLETION RATE WAS CONSIDERED NORMAL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT WAS RECEIVING EFFECTIVE TREATMENT. SEE ALSO MANUFACTURER'S REPORT # 6000153-2014-00025.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2014. THE PATIENT HAD LEAD REMOVED AND HAD REVISION AS WELL AS BATTERY WAS REPLACED. BATTERY DEPLETION WAS NOTED AS NORMAL. THERE WAS NO PATIENT INJURY. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106054 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention