BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3132429 · Received May 29, 2013

    Report

    Report Number
    3007566237-2013-01753
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    February 20, 2013
    Report Date
    May 7, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ABOUT TWO AND A HALF MONTHS PRIOR TO REPORT, IT WAS INDICATED THAT THE ¿IMPLANT WAS NOT WORKING.¿ THE PATIENT WAS THREE WEEKS POST IMPLANT AND WAS HAVING MORE LEAKING EPISODES THAN BEFORE. WHEN THE PATIENT WOULD SNEEZE, COUGH, OR WALK, THEY WOULD HAVE LEAKAGE. AS OF THE DATE OF THIS REPORT, IT WAS REPORTED THE PATIENT WAS ¿WETTING¿ HERSELF, HAVING DIFFICULTY URINATING, HAVING BOWEL ISSUES, AND PAIN. IT WAS THOUGHT THAT THESE WERE RELATED TO A URINARY TRACT INFECTION. THE PATIENT RECEIVED ANTIBIOTICS AND THOUGHT THAT WAS HELPING THEIR PAIN. IT WAS INDICATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON. THE PATIENT WAS ON PROGRAM 2 AT 0.75V AND FELT IT ¿MORE IN THE ANUS.¿ THE INS WAS TURNED OFF UNTIL THE PATIENT COULD MEET WITH THEIR SURGEON. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237150 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention