BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2604512 · Received June 8, 2012

    Report

    Report Number
    3004209178-2012-04216
    Event Type
    Malfunction
    Date Received
    June 8, 2012
    Report Date
    May 12, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3986A, LOT# N132039, IMPLANTED: (B)(6) 2011, EXPLANTED: NA. PRODUCT TYP: LEAD: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYP: PROGRAMMER, PATIENT: PRODUCT ID 37092, SERIAL# UNK. PRODUCT TYP: EXTERNAL ANTENNA: PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: NA. PRODUCT TYP: EXTENSION. (B)(4). ANALYSIS OF PATIENT PROGRAMMER MODEL# 37743, SERIAL# (B)(4) SHOWED THE ANTENNA JACK WAS BROKEN. THE ANTENNA JACK AND SCRATCHED FACEPLATE WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST THE STIMULATION ON HER IMPLANTABLE NEUROSTIMULATOR (INS). WHEN THE PATIENT USED HER ANTENNA WITH THE PATIENT PROGRAMMER, THE INS WOULD TURN ON AND OFF SPORADICALLY. THIS ISSUE HAD OCCURRED FOR THE PAST WEEK. THE PATIENT NOTED THERE WAS A KINK IN THE WIRE THAT LOOKED DAMAGED. SHE ALSO NOTED SHE HAS TITANIUM "HARDWARE" IMPLANTED "ALL OVER" HER BODY. BECAUSE OF THIS, THE PATIENT HAD DIFFICULTY USING THE PROGRAMMER WITHOUT THE ANTENNA. THE PATIENT STATED SHE HAD THE INS FOR SPINAL FUSION PAIN THAT WENT FROM C1 DOWN TO T4-T6 AND WAS ON BED REST. THE REPAIR DEPARTMENT WAS CONTACTED ABOUT THE PATIENT'S ANTENNA AND IT WAS NOTED THE PATIENT HAD AN APPOINTMENT WITH HER PAIN DOCTOR FOR (B)(6) 2012. ADDITIONAL INFORMATION WAS RECEIVED TWO DAYS LATER THAT REPORTED THE STIMULATION GOT STUCK ON AND THE PATIENT EXPERIENCED SPLITTING HEADACHES, DOUBLE VISION, AND LEG CRAMPS. THESE SYMPTOMS HAD BEEN OCCURRING FOR THE PAST MONTH. THE PATIENT ALSO EXPERIENCED ITCHINESS IN HER EYES FOR THE LAST 6-8 WEEKS, ESPECIALLY WHEN HER STIMULATION WAS STUCK ON. THE PATIENT STATED THAT WHEN THE STIMULATION WAS STUCK ON, IT WAS TOO STRONG AND COULD NOT BE ADJUSTED DOWN. THE PATIENT MISSED HER DOCTOR APPOINTMENT THAT DAY, BUT ALSO HAD AN APPOINTMENT WITH HER GASTROINTESTINAL DOCTOR TOMORROW BECAUSE SHE HAD NOT HAD A BOWEL MOVEMENT IN FOUR WEEKS. THE PATIENT ALSO HAD URINATION ISSUES AND HAD TO USE A CATHETER. THE PATIENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS STILL HAVING CONERNS ABOUT THE DEVICE AND THERAPY. THE PATIENT WAS HAVING DIFFICULTY CONTACTING HER HEALTH CARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1