BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

    MDR report key: 6015145 · Received October 10, 2016

    Report

    Report Number
    3007566237-2016-03514
    Event Type
    Injury
    Date Received
    October 10, 2016
    Date of Event
    September 14, 2016
    Report Date
    October 10, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-28, LOT# VA17U1W, IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A MANUFACTURER REPRESENTATIVE (REP) REPORTED THE PATIENT'S SON CUT THE EXTERNAL WIRES WITH A CUTTERS DURING THE ADVANCED EVALUATION. THE REP NOTED PATIENT COMPLIANCE, THE PATIENT WAS GIVEN ANTIBIOTICS. THE REP STATED THERE WERE NO INTERVENTIONS OR ACTIONS TAKEN TO RESOLVE THE ISSUE, THE PATIENT MOVED ON TO STAGE 2 TO PREVENT INFECTION. THE REP NOTED THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION FROM A TRIAL PATIENT REPORTED SHE STARTED BLEEDING REAL BAD AND WENT TO CHANGE BANDAGE AND WAS NOT SURE IF TAPE WAS STUCK TO IT AND PULLED IT OUT. THE PATIENT STATED A LITTLE WIRE IS HANGING LOOSE, THERE WERE NOT SURE IF IT WAS THE BROWN WIRE. THE PATIENT STATED THE MACHINE IS NOT WORKING EITHER, NOT PICKING IT UP. THE PATIENT NOTED SHE FEELS A LITTLE WEAK. THE PATIENT STATED LAST NIGHT THE PATIENT FELT LIGHT HEADED AND HAD TO GO TO SLEEP. THE PATIENT NOTED IT STARTED ON THE AFTERNOON OF (B)(6). THE PATIENT PUT IN TWO DOCTOR'S APPOINTMENTS YESTERDAY. THE PATIENT NOTED SHE STILL FEELS REALLY WEAK. THE INDICATION FOR USE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665605 STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention