BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTERNAL NEUROSTIMULATOR

    MDR report key: 2617303 · Received June 15, 2012

    Report

    Report Number
    3007566237-2012-01361
    Event Type
    Injury
    Date Received
    June 15, 2012
    Report Date
    May 9, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3057 LOT#. SERIAL# UNKNOWN. IMPLANTED: EXPLANTED: PRODUCT TYP SCREENING DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON (B)(6) 2012 THAT A TRIAL PATIENT HAD A PNE DONE LAST WEEK. WHEN THE PATIENT CAME IN TODAY TO HAVE THE PNE TRIAL LEAD REMOVED, THE ENTIRE LEAD HAD BEEN PULLED OUT AND APART AND THE SURGEON NOTED THAT THE BALL TIP ON THE END OF THE LEAD APPEARED TO BE MISSING. THE SURGEON CONDUCTED X-RAYS AND PALPATION AND NEITHER OF THESE METHODS PRODUCED THE POTENTIAL FRAGMENT. OTHER THAN THIS MISSING FRAGMENT THE HEALTH CARE PROFESSIONAL HAD NOT REPORTED ANY OTHER THERAPY/DEVICE RELATED CONCERNS (E.G. PATIENT WAS NOT NOTING ANY PAIN OR DISCOMFORT) THE HEALTHCARE PROFESSIONAL BELIEVED THAT THE LEAD WAS DAMAGED DUE TO PATIENT'S RESTLESS SLEEPING. THE PATIENT WAS REFERRED FOR A STAGED TRIAL/IMPLANT. ADDITIONAL REPORTING FROM (B)(6) 2012 NOTED THAT THE PATIENT HAD A FLAT PLATE X-RAY DONE WHICH WAS REVIEWED BY TWO RADIOLOGISTS AND THERE WAS NO EVIDENCE OF ANY PIECE OF THE LEAD LEFT BEHIND. IT WAS PLANNED THAT THE PATIENT WOULD UNDERGO STAGE 1 IMPLANT ON JUNE 15 AND THEY PLANNED TO LOOK UNDER FLURO AGAIN AT THAT TIME TO VERIFY THAT NOTHING WAS THERE. AS OF REPORTING FROM (B)(4) 2012 THERE WAS NO CURRENT BUMPS OR IRRITATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT GO TO IMPLANT. THERE WAS NO EVIDENCE OF ANYTHING REMAINING IN THE PATIENT UNDER FLUOROSCOPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention