BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1932027 · Received November 30, 2010

    Report

    Report Number
    3004209178-2010-10042
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 18, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT WAS EXPERIENCING A SURGING SENSATION WHEN SHE TURNED HER HEAD A CERTAIN WAY. THE STIMULATION WAS ALSO TURNING ON AND THE PT COULDN'T TURN IT OFF WITH THE PT PROGRAMMER; THE PT WAS ABLE TO USE A MAGNET TO SHUT IT OFF, BUT IT KEPT TURNING BACK ON AND THE PT DIDN'T LIKE IT. IT WAS NOTED THAT THE PT HAD BEEN IN THE HOSPITAL FOR APPROX 12 WEEKS FOR REMOVAL OF HER GALL BLADDER, APPENDIX, FEMALE ORGANS AND AN ULCER. THE PT WAS RELEASED (B)(6) 2010. THE PHYSICIAN DOING THE SURGERY HAD BEEN NOTIFIED ABOUT THE PT'S IMPLANT, BUT IT WAS UNK IF THE PHYSICIAN HAD OBTAINED COMPATIBILITY INFO PRIOR TO THE SURGERY. THERE HAD BEEN NOTHING ELSE RECENTLY TO IMPACT THE DEVICE. WHEN DOING A PT PROGRAMMER SELF TEST, THERE WERE NO LIGHTS AND NO BEEP. THE PT WAS UNSURE WHEN THE LAST TIME THE PT PROGRAMMER BATTERY WAS CHANGED, BUT THOUGHT IT MIGHT HAVE BEEN JUNE. THE PT USED THE STIMULATION FOR HER HAND; IT WAS NOTED THAT IF THE STIMULATION WAS SHUT OFF UNTIL IT COULD GET CHECKED, THE PT'S HAND WOULD TURN BLUE, GET COLD, AND THEN TURN BLACK. THE PT DID NOT HAVE A MANAGING PHYSICIAN FOR HER STIMULATION SYSTEM DUE TO A MOVE AND WAS BEING SEEN BY HER FAMILY PHYSICIAN. ON (B)(6) 2010, THE FAMILY PHYSICIAN REPORTED THAT THE PT WAS HAVING DIFFICULTY FINDING A DEVICE MANAGING PHYSICIAN, BUT THEY WERE CONTINUING TO TRY. IT WAS ALSO REPORTED THAT SINCE (B)(6) 2010, THE PT HAD BEEN GETTING SHOCKING AND JERKING IN HER ARM WHEN THE STIMULATION WAS ON; THE PT ALSO HAD SWELLING IN HER ARM AREA. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR IMPLANTED:| PROGRAMMER: MODEL 7434A, LOT# NGL026204P| EXPLANTED:| EXTENSION: MODEL 7496-51, LOT# YR0006541N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3986, LOT# NAM001323N