BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2904893 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-00377
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 29, 2020
    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

    PRODUCT ID, 3093-28 LOT# V307391, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3093-28, LOT# V307391, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) MODEL 3058, SERIAL (B)(4) SHOWED NO SIGNIFICANT ANOMALIES THAT THE SET SCREW WAS BACKED OUT BEYOND THE POINT OF BEING ABLE TO ENGAGE WITH THE CONNECTOR BLOCK. THE DEVICE WAS SUBJECTED TO A SERIES OF STANDARD TESTS THAT INCLUDE (BUT NOT LIMITED TO) VISUAL INSPECTION, OUTPUT, AND TELEMETRY TESTING, AND FINAL FUNCTIONAL TESTING ANALYSIS OF LEAD MODEL 3093-28-28, LOT # V307391 SHOWED THAT THE #0 CONNECTOR WAS CRUSHED, THAT THE BODY OF THE INSULATION WAS CUT THROUGH, AND THE LEAD WAS SEGMENTED. THE CONTINUITY WAS ACCEPTABLE AND NO SHORTS BETWEEN CIRCUITS WERE NOTED. THE LEAD WAS SUBJECTED TO A SERIES OF STANDARD TESTS THAT INCLUDED BUT NOT LIMITED TO VISUAL INSPECTION AND ELECTRICAL TESTING. DUE TO INDRF HARMONIZATION, ANY PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSIONS CODES NO LONGER APPLY TO THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED, THERE WERE HIGH IMPEDANCES WHEN TESTED AT 2.0V. IT WAS STATED ONLY COMBINATIONS WITH ELECTRODE 0 WERE GREATER THAN 4,000 OHMS. IT WAS INDICATED "THEY CLOSED WITH THAT." ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD NOT HAD SYMPTOM RELIEF. ELEVEN DAYS LATER IT WAS STATED THAT THE PATIENT WAS SCHEDULED FOR BOTOX. THIS INFORMATION WAS ALSO REPORTED IN MANUFACTURER REPORT #3004209178-2013-00387 REGARDING PATIENT'S PREVIOUS IMPLANTABLE NEUROSTIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10732 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR