BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2930855 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01007
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 8, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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

    FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (SERIAL # (B)(4)) REVEALED THE FOLLOWING: THE SETSCREW WAS BACKED OUT TOO FAR. FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (SERIAL # (B)(4)) REVEALED THE FOLLOWING: THE SETSCREW WAS BACKED OUT TOO FAR.

    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 THAT THE SURGEON TRIED 2 IMPLANTABLE NEUROSTIMULATORS (INSS) AND 2 TORQUE WRENCHES BUT WAS UNABLE TO TIGHTEN THE SET SCREWS IN THE HEADER BLOCK EVEN AFTER HEARING 'CLICKS.' IT WAS NOTED THAT THE LEAD WAS STILL ABLE TO BE PULLED OUT. THE REPORTER STATED THAT THE ISSUE HAPPENED INTRA-OPERATIVELY ON BOTH INSS. IT WAS POSSIBLE TO GET THE 3RD NEW INS TIGHTENED WITHOUT ISSUES. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. INFORMATION ALSO REPORTED ON OTHER INS IN MANUFACTURER'S REPORT # 3004209178-2013-01006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37077 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1