BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 173836 · Received June 24, 1998

    Report

    Report Number
    MW1014048
    Event Type
    Other
    Date Received
    June 24, 1998
    Date of Event
    May 1, 1994
    Report Date
    June 24, 1998
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE RPTR, IN MAY 1992 SHE HAD A LAPAROSCOPIC PROCEDURE FOR THE PURPOSE OF DIAGNOSING HER LEFT SIDED PELVIC PAIN. SHE WAS DIAGNOSED WITH ENDOMETRIOSIS ALTHOUGH ACCORDING TO THE RPTR SHE PREVIOUSLY HAD A HYSTERECTOMY. DURING THIS PROCEDURE, A TROCAR "FELL APART." THE RPTR BELIEVES PARTS OF THE TROCAR AND SOME UNUSED STAPLES REMAIN IN HER BODY. ACCORDING TO HER CHART, HER COLON, URINARY BLADDER, AND A URETER WERE DAMAGED, BUT OTHER PHYSICIANS HAVE FOUND NO EVIDENCE OF THIS "DAMAGE". IN MAY 1994, THE RPTR HAD A BLADDER SUSPENSION TO CORRECT URINARY INCONTINENCE. IT IS DURING THIS PROCEDURE THAT A "STIMULATOR" WAS ALLEGEDLY IMPLANTED WITHOUT HER KNOWLEDGE OR CONSENT. ACCORDING TO THE RPTR, IN 1996 SHE BEGAN EXPERIENCING "ELECTROMAGNETIC SHOCKS" THROUGHOUT HER BODY. REPORTEDLY, SHE IS ABLE TO PREDICT WHEN THE TELEPHONE WILL RING SECONDARY TO A "SENSATION" WHICH OCCURS IN HER EARS. THE RPTR ALSO HAS OTHER "SENSATIONS" RELATED TO VARIOUS FORMS OF COMMUNICATION. THE IMPLANTATION OF THE DEVICE WAS CONFIRMED BY THE PHYSICIANS SECRETARY. THE RPTR BELIEVES THE DEVICE IS TESTED DAILY FOR TRACKING HER VIA SATELLITE IMAGING TECHNOLOGY AS WELL AS INTENTIONALLY INDUCING PAIN FOR ABUSIVE PURPOSES. THE RPTR BELIEVES THE DEVICE WAS NOT FDA APPROVED AT THE TIME OF IMPLANTATION AND TO HER KNOWLEDGE, THE DEVICE WAS TO BE USED FOR PAIN MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK Implant STIMULATOR GZB MEDTRONIC, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other