BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2101681 · Received May 11, 2011

    Report

    Report Number
    3004209178-2011-03430
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 13, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REC'D INFO THE PT DEVELOPED HIGH IMPEDANCES ABOUT ONE MONTH AFTER IMPLANT. IMPEDANCES WERE >4000 OHMS ON ALL OR SOME UNIPOLAR PAIRS. THE MFR'S REP WAS IN THE PROCESS OF REPROGRAMMING TO TRY AND RECAPTURE THERAPEUTIC STIMULATION. IT WAS INDICATED THE PHYSICIAN ALWAYS TESTS IMPEDANCES BEFORE CLOSING AND AT THE FIRST F/U VISIT AND THERE WERE NO KNOWN ISSUES AT THOSE TIMES. ADD'L INFO HAS BEEN REQUESTED AND IF REC'D, A F/U REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3023 H0280503

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR PROGRAMMER: MODEL 3037, LOT# NJD117083N| IMPLANTED:| LEAD: MODEL 3093, LOT# V519211| EXPLANTED: