BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_UNKNOWN_LEAD

    MDR report key: 2457289 · Received February 16, 2012

    Report

    Report Number
    3007566237-2012-00343
    Event Type
    Injury
    Date Received
    February 16, 2012
    Date of Event
    June 14, 2011
    Report Date
    February 15, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL EVENT DATE IS UNKNOWN. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME NO ADDITIONAL INFORMATION WAS AVAILABLE, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: FAUCHERON JL, HERAULT MC. LIFE THREATENING HAEMORRHAGE AFTER ELECTRODE REMOVAL: A SEVERE COMPLICATION FOLLOWING SACRAL NERVE STIMULATION PROCEDURE FOR THE TREATMENT OF FAECAL INCONTINENCE. COLORECTAL DIS 2011, 14: EL 133. DOI: 10.1111/J.1463-1318.2011.02794.X. SUMMARY: THIS ARTICLE PRESENTS A CASE STUDY OF AN OBESE (B)(6) WOMAN WITH A HISTORY OF DIABETES MELLITUS, A PULMONARY EMBOLISM AND A HYSTERECTOMY FOR BENIGN DISEASE WHO UNDERWENT PLACEMENT OF A TINED ELECTRODE IN THE SACRAL FORAMEN FOR TEST STIMULATION DUE TO FECAL INCONTINENCE. NEGATIVITY OF THE TEST STIMULATION AND THE NEED TO PERFORM AN MRI FOR LUMBAR PAIN LED TO ELECTRODE REMOVAL WHICH WAS COMPLICATED BY A SUDDEN HEMORRHAGE. REPORTABLE EVENT: UPON REMOVAL OF THE TINED ELECTRODE AFTER AN UNSUCCESSFUL TRIAL, THE PATIENT EXPERIENCED A SUDDEN HEMORRHAGE COMING FROM THE ANTERIOR PART OF THE SACRAL FORAMEN. DESPITE ENLARGEMENT OF THE WOUND TO GET BETTER EXPOSURE, HEMOSTASIS WAS NOT POSSIBLE USING ELECTROCAUTERY, SUTURES AND HEMOSTATIC GAUZE. THE OPERATION ENDED WITH EFFICIENT APPLICATION OF A COMPRESSION DRESSING OVER THE SACRUM. THE PATIENT RE-BLED THE FIRST DAY AND WAS REOPERATED FOR A NEW COMPRESSION DRESSING. AN ANGIOGRAPHY CONFIRMED THE ABSENCE OF PERSISTENT BLEEDING. THE PATIENT WAS TRANSFUSED WITH THREE PACKED RED CELL UNITS AND WAS ADMITTED TO THE INTENSIVE CARE UNIT FOR 2 DAYS. THE ABSENCE OF BLEEDING ALLOWED THE PROGRESSIVE RISE AND MOBILIZATION OF THE COMPRESSIVE MESHES IN THE SURGICAL WARD. ELEVEN DAYS AFTER THE SECOND OPERATION WHILE STILL IN THE SURGICAL WARD, THE PATIENT EXPERIENCED HEMORRHAGIC SHOCK ONCE AGAIN DUE TO BLEEDING FROM THE SACRAL FORAMEN. CENTRAL VENOUS ACCESS WAS INSERTED. HEMODYNAMIC SHOCK RESPONDED TO REOPERATION WITH COMPRESSIVE DRESSING, TRANSFUSION OF FOUR PACKED RED CELL UNITS AND INFUSION OF NORADRENALIN. CT SCAN SHOWED NO ACTIVE BLEEDING. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR 4 DAYS. ON DAY 13, THE PATIENT UNDERWENT REMOVAL OF THE COMPRESSIVE DRESSING UNDER GENERAL ANESTHESIA. BACTERIOLOGICAL EXAMINATION FROM THE GAUZE SHOWED INFECTION WITH MULTIRESISTANT KLEBSIELLA PNEUMONIA AND ESCHERICHIA COLI THAT REQUIRED PERFUSION WITH ERTAPENEM, TRIMETHOPRIM AND SULFAMETHOXAZOLE FOR 2 WEEKS. ON DAY 17, THE PATIENT RETURNED TO THE SURGICAL WARD WHERE DRESSING WAS DONE EVERY DAY. THE PATIENT WAS DISCHARGED 32 DAYS AFTER ELECTRODE REMOVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Hospitalization| L| R