BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4122088 · Received September 26, 2014

    Report

    Report Number
    3007566237-2014-02711
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS NO TELEMETRY POSSIBLE DURING IMPEDANCE TESTING AT THE TIME OF IMPLANT. ALL POSSIBLE CAUSES WERE RULED OUT, THEY HAD CHANGED PHYSICIAN PROGRAMMERS, "POSITION ON PATIENT, WITH AND WITHOUT PLUGGED ELECTRODE, IN AND OUT OF THE BODY, ECT.¿ A SECOND IMPLANTABLE NEUROSTIMULATOR (INS) WAS USED TO TRY AND GAIN TELEMETRY BUT TELEMETRY WAS NOT POSSIBLE. NOTHING HAD WORKED SO ALL POSSIBLE INTERFERENCE FIELDS AROUND THE PATIENT WERE CHECKED. AFTER REMOVAL OF THE ¿OP-LAMP (BERCHTOLD)¿ THE IMPEDANCE MEASUREMENT WAS OKAY WITH BOTH NEUROSTIMULATORS. THERE WAS A PRODUCT ISSUE AND IT WAS RESOLVED. THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT AND THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600359 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR