BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3171098 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10422
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE, MODEL # 3058 SN (B)(4), FOUND THE SETSCREW TO BE BACKED OUT TOO FAR. ANALYSIS OF THE TORQUE WRENCH FOUND NO ANOMALY. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_WRENCH_ACC; PRODUCT TYPE ACCESSORY. (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

    (B)(4).

    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 SCREW "WOULD NOT WORK". THE DOCTOR ATTEMPTED 5 TIMES TO GET THE SCREW TO WORK PROPERLY. THE DEVICE WAS NOT IMPLANTED. ANOTHER IMPLANT WAS USED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE UROLOGIST HAD ISSUE WITH SECURING OF THE LEAD TO THE IMPLANTABLE NEUROSTIMULATOR (INS) AND IT SEEMED THAT THE SCREW ON THE TOP OF THE INS WAS STRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270885 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR