BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2942033 · Received February 4, 2013

    Report

    Report Number
    3004209178-2013-01263
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    February 25, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37746, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STIMULATION IN PATIENT'S KNEES AREA HAD STOPPED ONE DAY BEFORE THE REPORT AND NOW IT WAS ONLY FELT IN HER FEET. IT WAS STATED THAT THE PATIENT EXPERIENCED CONSTIPATION YESTERDAY AND "WORKED HARD" TO GO TO RESTROOM. THE SYMPTOMS WERE PAIN AND NOT GETTING STIMULATION WHERE SHE USED TO FEEL IT. PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS ADJUSTED TO ONLY ONE PROGRAM APPROXIMATELY 1-1.5 WEEKS AGO. IT WAS STATED THAT THE PATIENT HAD MORE THAN ONE PROGRAM BEFORE THIS ADJUSTMENT. THE ADJUSTMENT WAS DONE TO ADDRESS THE PATIENT "HAVING ISSUES WITH PROGRAMS" AND ALSO NOT FEELING THE STIMULATION IN HER KNEES. IT WAS ALSO REPORTED THAT IT WAS NOT POSSIBLE TO ADJUST STIMULATION. AFTER TROUBLESHOOTING, SYNCING WAS ACHIEVED, BUT IT WAS STATED THAT THERE WAS A LIGHTNING BOLT AND A 1 WITH NO LETTERS OR CHECKS ON THE PATIENT PROGRAMMER SCREEN WITH AMPLITUDE BEING 1.05V. AFTER FURTHER TROUBLESHOOTING IT WAS MENTIONED THAT THE PATIENT COULD NOW FEEL THE STIMULATION AT 1.85V BUT IT WAS ONLY IN THE FEET AND STILL NOT IN THE KNEES. REPROGRAMMING TO ADDRESS STIMULATION NEEDS WAS SUGGESTED. PAIN OVER IMPLANT SITE WAS ALSO REPORTED. THE INS SERIAL NUMBER WAS NOT AVAILABLE IN THE MANUFACTURER'S DATABASE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE PROVIDER INDICATED THE PATIENT WAS GETTING "GOOD" STIMULATION COVERAGE, BUT "JUST WASN'T HAPPY WITH AMOUNT OF PAIN RELIEF," PROMPTING AN EXPLANT. IT WAS REPORTED THAT ALL IMPEDANCES WERE WITHIN NORMAL LIMITS. IT WAS NOTED THERE WERE NO INJURY OR HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47091 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention