BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2200852 · Received August 8, 2011

    Report

    Report Number
    3007566237-2011-06135
    Event Type
    Injury
    Date Received
    August 8, 2011
    Report Date
    May 2, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: HODA MR, FORNARA P. [SACRAL NEUROMODULATION IN UROLOGY. THE EMPEROR'S NEW CLOTHES OR EFFECTIVE HIGH-TECH MEDICINE]. UROLOGE A. OCT 2010;49(10);1254-1259. SUMMARY: IN THE PERIOD FROM (B)(6) 2009 TO (B)(6) 2010, 42 PATIENTS UNDERWENT PNE TESTING FOR SACRAL NEUROMODULATION (SNM). OF THESE, 35 PATIENTS HAD A SUCCESS RATE OF (B)(6) AND CONSEQUENTLY REC'D AN IMPLANTED DEVICE; RESULTS OF THIS THERAPY AFTER A MID-TERM F/U TIME OF 7.8 MONTHS WERE DESCRIBED BY THE AUTHORS. REPORTABLE EVENT: IT WAS REPORTED THAT ONE PT EXPERIENCED PAIN AT THE IMPLANTABLE NEUROSTIMULATOR IMPLANT SITE. ADD'L INFO REC'D INDICATED THAT THE PT'S CHRONIC PAIN WAS IN THE LEFT GLUTEAL AREA, AND WAS REFRACTORY TO PAIN MEDICATION. APPROX ONE YEAR AFTER SUCCESSFUL IMPLANT, THE DEVICE WAS EXPLANTED. THE PT WAS REIMPLANTED VENTRALLY IN THE LOWER LEFT ABDOMINAL REGION WITH A UNILATERAL SYSTEM. SEE MFR REPORT # 3007566237-2011-00884 FOR A COPY OF THE LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC NEUROMODULATION 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention LEAD: MODEL LEAD URO, LOT # UNK| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT # UNK