BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SACRAL NERVE IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 1624500 · Received February 24, 2010

    Report

    Report Number
    3007566237-2010-01446
    Event Type
    Injury
    Date Received
    February 24, 2010
    Date of Event
    December 31, 2010
    Report Date
    January 28, 2010
    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).

    Description of Event or Problem · 1

    LITERATURE: GOVAERT B, MELENHORST , NIEMAN FHM, BOLS EMJ, VAN GEMERT WG, BAETEN CG. FACTORS ASSOCIATED WITH PERCUTANEOUS NERVE EVALUATION AND PERMANENT SACRAL NERVE MODULATION OUTCOME IN PTS WITH FECAL INCONTINENCE. DIS COLON RECTUM. 2009; 52(10): 1688-94. SUMMARY: THIS ARTICLE PRESENT A RETROSPECTIVE COHORT ANALYSIS OF PTS WHO UNDERWENT A PERCUTANEOUS NERVE EVALUATION (PNE) BETWEEN (B) (4) 2000 AND (B) (4) 2007 AT ONE MEDICAL CENTER AND WERE DIAGNOSED WITH FECAL INCONTINENCE TO DETERMINE WHICH FACTORS COULD PREDICT PNE OUTCOME AND WHETHER POSSIBLE FACTORS MAY EXCLUDE PTS FORM THE TREATMENT. A SECONDARY PURPOSE WAS TO DETERMINE WHICH FACTORS COULD PREDICT THE OUTCOME OF PERMANENT SACRAL NERVE MODULATION. ALL 245 PTS MET THE INCLUSION CRITERIA FOR THE STUDY AND UNDERWENT A PNE IN THE STUDY TIME FRAME. BEFORE THE PNE PROCEDURE, A BASELINE 3-WEEK BOWEL HABIT DIARY WAS COMPLETED. A PNE AND PERMANENT SACRAL NERVE STIMULATION SUCCESS WAS CONSIDERED A >50% DECREASE IN THE NUMBER OF INCONTINENCE EPISODES AS DETERMINED BY A 3-WEEK BOWEL HABIT DIARY. REPORTABLE EVENT: FOUR PTS EXPERIENCED INFECTION REQUIRING EXPLANT OF THE SYSTEM WITHOUT NEW IMPLANT. SEE LITERATURE ARTICLE WITH MFR REPORT #3007566237201001442.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SACRAL NERVE IMPLANTABLE NEUROSTIMULATOR EZW MEDTRONIC NEUROMODULATION UNK NA

    Patients

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