BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 7649850 · Received June 29, 2018

    Report

    Report Number
    3004209178-2018-14633
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    June 16, 2018
    Report Date
    June 29, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00613994610430
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR RADICULAR PAIN SYNDROME (RADICULOPATHIES) AND SPINAL PAIN. IT WAS REPORTED THAT PATIENT WAS LOOKING FOR MANUFACTURING REPRESENTATIVE (REP) TO PROGRAM HIS ADAPTIVE STIMULATION BECAUSE IT WAS NOT "SWITCHING OVER" TO THE CORRECT AMPLITUDE HE NEEDED FOR THE POSITION HE WAS IN/POSITION WAS NOT CHANGING TO CORRECT POSITION HER WAS IN. PATIENT SAID HE HAD ADAPTIVE STIMULATION ORIGINALLY PROGRAMMED TO ADJUST FOR ONLY 2 POSITIONS, LAYING BACK AND UPRIGHT. SUNDAY HE NOTICED THAT THE AMPLITUDE OF HIS LAYING BACK POSITION RAN UP TO ABOUT 9 V WHEN NORMALLY IT IS A 2.50V AND SHOCKED HIM TO DEATH BEFORE HE COULD GET IT TURNED BACK DOWN WHEN HE WAS LAYING DOWN AND HIS LEGS ALMOST JUMPED OFF THE BED. PATIENT SAID THE LAST DAY OR SO ADAPTIVE STIM TO BE WORKING NORMALLY FOR HIM. PATIENT SAID THAT ALL OF A SUDDEN HE STARTED SEEING THE "LAYING LEFT" AND "LAYING RIGHT" POSITIONS APPEAR ON HIS PROGRAMMER WHEN HE HAD NEVER SEEN THEM BEFORE AND HE DID NOT KNOW HOW THEY GOT THERE. TROUBLESHOOTING PERFORMED. REVIEWED WITH PATIENT THAT WHEN DEVICE IS ORIENTED 3 POSITIONS MUST BE SELECTED, AND IF PATIENT DIDN'T WANT TO USE THE 3RD POSITION IT WOULD BE SET AT 0.0V SO PATIENT WOULDN'T NOTICE ANY CHANGE. IT APPEARS AS THOUGH 'LAYING BACK" AND 'UPRIGHT' WAS SELECTED ALONG WITH THE 'LAYING LEFT' (LAYING LEFT WILL ALSO ACTIVE LAY RIGHT IT WAS COUNTED AS ONE POSITION ALL TOGETHER). PATIENT SAID THAT HE NEVER GETS INTO THE LAYING POSITION WHICH MIGHT EXPLAIN WHY HE SAW IT ON SUNDAY FOR THE FIRST TIME, AS HE MAY HAVE BEEN LAYING ON HIS SIDE AND ACCIDENTLY ADJUSTED STIMULATION. HAD PATIENT CHECK POSITIONS THE LAYING BACK AND UPRIGHT POSITIONS REGISTERED CORRECTLY AND WERE ON THE AMP. PATIENT WANTED IT ON. PATIENT CHECKED POSITION AND LAYING R AND LAYING WERE BOTH SET ON 2.50, HELPED PATIENT LOWER STIM TO 0.0V. AFTER TROUBLESHOOTING ADAPTIVE STIMULATION SEEMED FULLY FUNCTIONING. PATIENT HAS APPOINTMENT WITH HEALTH CARE PROFESSIONAL (HCP) ON (B)(6) 2018. NO FURTHER PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493283 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714 00613994610430

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR