BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2190351 · Received July 25, 2011

    Report

    Report Number
    3007566237-2011-05716
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    September 17, 2010
    Report Date
    July 19, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IS THE AVERAGE FOR ALL THE PATIENTS; GENDER INFORMATION WAS NOT PROVIDED. AT THIS TIME, NO ADDITIONAL INFORMATION WAS AVAILABLE, ADD'L INFO REGARDING THE PATIENT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: MARINKOVIC SP, GILLEN LM, MARINKOVIC CM. MINIMUM 6-YEAR OUTCOMES FOR INTERSTITIAL CYSTITIS TREATED WITH SACRAL NEUROMODULATION. INT UROGYNECOL J PELVIC FLOOR DYSFUNCT. APR 2011;22(4):407-412. DOI 10.1007/S00192-010-1235-9. SUMMARY: THE AUTHORS PERFORMED AN OBSERVATIONAL, RETROSPECTIVE, CASE-CONTROLLED REVIEW ((B)(6) 2002 - (B)(6) 2004), TO DISCERN WHETHER NEUROMODULATION COULD BE SUCCESSFULLY IMPLEMENTED WITH ACCEPTABLE MORBIDITY RATES IN INTERSTITIAL CYSTITIS PATIENTS WHEN STANDARD DRUG THERAPIES HAVE FAILED. THE AUTHORS INDICATED THAT SACRAL NEUROMODULATION IS BOTH THERAPEUTIC IN THE SHORT-TERM (MEAN 14 MONTHS) AND MEDIUM TERM (MEAN 6-7 YEARS) WITH GOOD OUTCOMES. THIRTY-FOUR FEMALE PATIENTS UNDERWENT STAGE 1 AND 2 INTERSTIM PLACEMENTS UNDER A GENERAL ANESTHETIC. REPORTABLE EVENT: THE AUTHORS REPORTED FIVE CASES OF LEAD MIGRATION AND THREE CASES OF DEVICE EROSIONS (SECONDARY TO ACCIDENTS E.G., KICK TO THE SIDE OF THE RIGHT BUTTOCKS DURING A MARTIAL ARTS BOUT, FALL OFF A 15-FOOT LADDER, FALL THROUGH A PORCH FLOOR, CAR DOOR SLAMMED AGAINST THE BUTTOCK DURING A TORNADO ALERT) WITHOUT INFECTION.

    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 41 YR Other LEAD: MODEL 3093, SERIAL NUMBER UNK| IMPLANT DATE: