BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STIMULATOR

    MDR report key: 2924223 · Received January 22, 2013

    Report

    Report Number
    3007566237-2013-00239
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 2, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL REPORTED THAT THEY HAD NO SPECIFICS REGARDING THE EVENT ALTHOUGH IT WAS NOTED THAT HIGH IMPEDANCE ISSUES AFTER PHYSICAL EVENTS WOULD HAVE MEANT THE PATIENT WOULD HAVE TO HAVE GONE BACK TO THE OPERATING ROOM. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEALTHCARE PROVIDER INFORMED THEIR PATIENT THAT ANOTHER PATIENT HAD BEEN HIT BY A SWINGING HALF DOOR IN THE COURTROOM AND HAD A "FAILURE". ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31102 UNKNOWN STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention