BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2555972 · Received May 2, 2012

    Report

    Report Number
    3007566237-2012-00949
    Event Type
    Injury
    Date Received
    May 2, 2012
    Date of Event
    November 16, 2011
    Report Date
    April 4, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    (B)(4). ABSTRACT: AIM GENTAMICIN-IMPREGNATED COLLAGEN (COLLATAMP) IS WELL DESCRIBED FOR THE PREVENTION OF INFECTION IN SURGERY. THIS TECHNICAL NOTE DESCRIBES ITS INTRAOPERATIVE USE AS A PROPHYLACTIC MEASURE TO PREVENT INFECTION FOLLOWING IMPLANTATION OF A SACRAL NERVE STIMULATOR FOR FAECAL INCONTINENCE. METHOD FOLLOWING IMPLANTATION OF THE INTERSTIM II NEUROSTIMULATOR (MEDTRONIC NEUROMODULATION (B)(4)) IN A SUBCUTANEOUS POCKET OVERLYING THE GLUTEAL MUSCLE, A SINGLE SHEET OF 10 CM - 10 CM GENTAMICIN-IMPREGNATED COLLAGEN IS PLACED WITHIN THE WOUND COVERING THE IMPLANT. THE SUBCUTANEOUS TISSUE AND SKIN ARE THEN CLOSED IN SEPARATE LAYERS. RESULTS TO DATE EIGHT PATIENTS [(B)(6)] HAVE RECEIVED PROPHYLACTIC COVER WITH GENTAMICIN- IMPREGNATED COLLAGEN FOLLOWING PERMANENT SACRAL NERVE STIMULATOR IMPLANTATION. AT A MEDIAN INTERVAL OF 89.5 (51 - 128) DAYS, NONE OF THESE PATIENTS DEVELOPED A WOUND INFECTION AT THE SITE OF THE NEUROSTIMULATOR IMPLANT. CONCLUSION GENTAMICIN-IMPREGNATED COLLAGEN (COLLATAMP) USED IN THE IMPLANTATION OF A SACRAL NERVE STIMULATOR MAY BE A USEFUL ADDITION TO THE TECHNIQUE. REPORTED EVENT: ALL PATIENTS WERE INSTRUCTED NOT TO REMOVE THE SUTURES FOLLOWING THE OPERATION, BUT ONE PATIENT DID SO ON THE SEVENTH POSTOPERATIVE DAY. THIS LED TO THE SKIN WOUND OPENING WITH POTENTIAL EXPOSURE OF THE IMPLANT. THE WOUND WAS RESUTURED AND THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS FOR 3 WEEKS. THE WOUND SUBSEQUENTLY HEALED WITHOUT INFECTION AND THE IMPLANT FUNCTIONED NORMALLY. THE ARTICLE INCLUDED THE FOLLOWING DEVICE SPECIFICS: IMPLANTATION OF THE INTERSTIM II NEUROSTIMULATOR (MEDTRONIC NEUROMODULATION (B)(4)) IN A SUBCUTANEOUS POCKET OVERLYING THE GLUTEAL MUSCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL UNKNOWN LOT UNKNOWN