BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM UNKNOWN

    MDR report key: 2181255 · Received July 22, 2011

    Report

    Report Number
    3007566237-2011-05697
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    March 1, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PT. THE PT INFO PROVIDED IN SECTION A IS THE AVERAGE FOR ALL THE PATIENTS. AT THIS TIME NO ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE PATIENTS AND EVENTS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: AL-ZAHRANI AA, ELZAYAT EA, GAJEWSKI JB. LONG-TERM OUTCOME AND SURGICAL INTERVENTIONS AFTER SACRAL NEUROMODULATION IMPLANT FOR LOWER URINARY TRACT SYMPTOMS: 14-YEAR EXPERIENCE AT 1 CENTER. THE JOURNAL OF UROLOGY. MAR 2011:183(3):981-986. DOI:10.10.1016/J.JURO.2010.10.054. SUMMARY: THE AUTHORS REPORT ON THEIR LONG-TERM RESULTS AND RE-OPERATIONS DURING A 14-YEAR SPAN USING SACRAL NEUROMODULATION. THEY RETROSPECTIVELY REVIEWED THE TRACT DYSFUNCTION BETWEEN 1994 AND 2008; 96 PERMANENT SACRAL NEUROMODULATION DEVICES WERE IMPLANTED IN 88 FEMALES AND 8 MALES FOR BLADDER PAIN SYNDROME, URGENCY INCONTINENCE AND IDIOPATHIC URINARY RETENTION. THERE WERE NO INFECTION EVENTS. REPORTED EVENT: SEVERAL PATIENTS HAD A SURGICAL INTERVENTION; THE IMPLANTED SYS WAS EITHER REMOVED OR REVISED. SYS REMOVAL OCCURRED IN: 12 PATIENTS DUE TO SYMPTOM DETERIORATION; 6 WERE REMOVED DUE TO PAINFUL STIMULATION AND 2 WERE REMOVED DUE TO STIMULATION RADIATION DOW TO THE LEG. SYS REVISION OCCURRED IN: 24 PATIENTS DUE TO SYMPTOM DETERIORATION; 5 PATIENTS DUE TO PAINFUL STIMULATION; 5 PATIENTS DUE TO IPG PAIN AND IN 7 PATIENTS DUE TO STIMULATION RADIATION DOWN TO THE LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM UNKNOWN EZW MEDTRONIC NEUROMODULATION IPG URO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention UNK LEAD