BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1246180 · Received November 26, 2008

    Report

    Report Number
    2182207-2008-07784
    Event Type
    Injury
    Date Received
    November 26, 2008
    Report Date
    November 5, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    JOURNAL REFERENCE: PETER KM, CAREY JM, KONSTAND DB. SACRAL NEUROMODULATION OF THE TREATMENT OF REFRACTORY INTERSTITIAL CYSTITIS: OUTCOMES BASED ON TECHNIQUE. INT URGYNECOL J PELVIC FLOOR DYSFUNCT. 2003; 14(4): 223-2328; DISCUSSION 228. PTS WITH REFRACTORY INTERSTITIAL CYSTITIS (IC) UNDERWENT TESTING WITH SACRAL NERVE MODULATION VIA EITHER A TRADITIONAL PERCUTANEOUS APPROACH OR STAGED PROCEDURE. IMPLANTED PTS WERE FOLLOWED WITH SCALED QUESTIONNAIRES AND VOIDING DIARIES. REPORTABLE EVENT: ONE PT WHO UNDERWENT IMPLANTATION AFTER A TRADITIONAL TEST, REQUIRED REVISION OF THE GENERATOR POCKET. SEE MFG REPORT# 2182207200807783.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC NEUROMODULATION 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other PROGRAMMER: MODEL UNK| LEAD: MODEL UNK. N=1