BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

    MDR report key: 5405502 · Received February 2, 2016

    Report

    Report Number
    3007566237-2016-00525
    Event Type
    Injury
    Date Received
    February 2, 2016
    Date of Event
    November 18, 2015
    Report Date
    January 11, 2016
    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

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    MARINKOVIC, S.P., MILLER, B., HUGHES, S., MARINKOVIC, C., GILLEN, L. SUCCESSFUL BILATERAL PUDENDAL NEUROMODULATION TO TREAT MALE DETRUSOR AREFLEXIA FOLLOWING SEVERE PUBIC SYMPHYSIS FRACTURE, A CASE REPORT. BMC UROLOGY. 2015;15:115. DOI 10.1186/S12894-015-0108-4. SUMMARY: SACRAL NEUROMODULATION MAY SUCCESSFULLY CORRECT TRAUMATIC URINARY RETENTION IN MALE PATIENTS. ADDITIONALLY, PUDENDAL NEURO MODULATION CAN BE SUCCESSFULLY UTILIZED AS A SALVAGE METHOD FOR AN INFECTED SACRAL NEUROMODULATION IMPULSE GENERATOR (IPG) AND TINED LEAD WITH A RETURN TO PROPER VOIDING. REPORTED EVENTS: A (B)(6) MALE WITH BILATERAL SACRAL NERVE STIMULATION (SNS) SYSTEMS FOR TRAUMATIC URINARY RETENTION HAD RETURNED TO WORK 6 MONTHS AFTER IMPLANT WHERE HIS UNIFORM WAS IRRITATING BOTH OF HIS IMPLANTS; WITHIN 3 WEEKS HE REPORTEDLY DEVELOPED BILATERAL CELLULITIS WITH PURULENT DRAINAGE FROM BOTH LEAD SITES AND IMPLANTABLE NEUROSTIMULATORS (INS), RESULTING IN BOTH SYSTEMS BEING EXPLANTED. IT WAS NOTED THAT EACH POCKET WOUND CULTURE GREW (B)(6) AND THE PATIENT WAS SUBSEQUENTLY TREATED WITH CIPROFLOXIN HOME INTRAVENOUS THERAPY FOR SIX WEEKS, ALONG WITHTHE RESUMPTION OF CLEAN INTERMITTENT CATHETERIZATION. THREE MONTHS LATER, RE-EXAMINATION REVEALED BOTH SITES TO BE WELL HEALED. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63366 STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention