BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3013288 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-03984
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    February 27, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE HAD BEEN "GOING OFF" SINCE THE MONDAY PRIOR TO THE REPORT, TO THE POINT THAT HER BODY WAS SHAKING. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEEN BY HER HEALTH CARE PROVIDER (HCP) A MONTH PRIOR TO THE REPORT AND THEY WERE UNABLE TO CLEAR A MESSAGE ON HER RECHARGER. THE PATIENT WAS INSTRUCTED TO CONTINUE TO CHARGE HER DEVICE. THE PATIENT REPORTEDLY CANNOT TURN OFF HER DEVICE. IT WAS ALSO REPORTED THAT ON (B)(6) 2013, THE PATIENT HAD BEEN DRIVING FOR 45 MINUTES AND WAS CHARGING WHEN SHE FELT A SHOCK LIKE ELECTRICITY AND VIBRATION/STIMULATION WAS SO STRONG, "LIKE LEVEL 10," THAT HER BODY WAS SHAKING AND BODY MOVEMENTS WERE UNCONTROLLABLE. THE PATIENT REPORTEDLY WAS TOLD BY A MANUFACTURE REPRESENTATIVE TO TURN OFF STIMULATION. IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE MONDAY PRIOR TO THE REPORT STIMULATION REPORTEDLY "CAME ON" AND THE PATIENT TRIED TO TURN STIMULATION OFF AND RECEIVED A POWER ON RESET (POR) MESSAGE. A PHYSICIAN MODE RESET (PMR) WAS ATTEMPTED BUT DID NOT SUCCEED IN TURNING STIMULATION OFF. IT WAS NOTED THAT THE PATIENT DID NOT SEE THE 60 MINUTE TIMER COME UP. A PMR WAS REPORTEDLY ATTEMPTED 2 ADDITIONAL TIMES AND ON THE SECOND ATTEMPT, STIMULATION WAS SUCCESSFULLY TURNED OFF. IT WAS NOTED THAT STIMULATION WAS OFF AND THE PATIENT HAD AN APPOINTMENT WITH HER HCP THE NEXT DAY. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT HAD A SUSPECTED OVERDISCHARGE CLEARED A MONTH PRIOR TO THE REPORT AND THERE WAS OVERSTIMULATION FOLLOWING THE OVERDISCHARGE. IT WAS NOTED THAT THE PATIENT DID NOT KNOW WHAT WAS CAUSING HER BODY TO SHAKE, SHE WAS NOT SURE IF IT WAS THE LEADS. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. IT WAS ALSO REPORTED THAT THE "WHATEVER MOVEMENT SHE DOES - PATIENT'S HEART BEAT WITH EACH MOVEMENT." IT WAS LATER REPORTED THAT THE PATIENT HAD BEEN OVERSTIMULATION ON HIGH SETTINGS FOR 2.5 DAYS. IT WAS NOTED THAT THE PATIENT WAS SHAKING WHEN "IT WAS ON HIGH AND ON" IT WAS LATER REPORTED THAT THE PATIENT'S BATTERY WAS OVERDISCHARGED. IT WAS NOTED THAT THE PATIENT WAS PROGRAMMED AND WAS RECEIVING GOOD THERAPY. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT WAS "NOT FEELING A FULL BURN OF IT WHEN THEY GOT UP AND THEY CAN'T HELP BUT FEEL THE SLIGHT BURN OF IT." IT WAS NOTED WHEN THE PATIENT WOULD STAND AND SIT UP, IT WOULD HURT SOMETIMES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON 2013-01-04 REPORTED THERE WAS A CONFIRMED IMPLANTABLE NEUROSTIMULATOR (INS) OVERDISCHARGE. THERE WERE TELEMETRY ISSUES. PROBLEMS WITH THE RECHARGE COUPLING WERE LIKELY THE REASON FOR THE OVERDISCHARGE AS THE PATIENT STATED SHE USUALLY ONLY GOT ABOUT HALF OF THE BARS. THE LAST SUCCESSFUL RECHARGING SESSION WAS ABOUT TWO MONTHS PRIOR TO THE REPORT. TWO ANTENNA LOCATES WERE PERFORMED AND NO POWER ON RESET (POR) WAS NOTED. A PHYSICIAN MODE RECHARGE WAS SUCCESSFULLY PERFORMED. WHILE THE DEVICE WAS OVERDISCHARGED, THE PATIENT WAS EXPERIENCING INCREASED PAIN SINCE SHE WAS UNABLE TO USE THE INS. THE PATIENT WAS INSTRUCTED TO FULLY CHARGE THE INS BEFORE RETURNING TO CLEAR THE POR. THE PATIENT PLANNED TO RETURN TO THE DOCTOR'S OFFICE WHEN SHE WAS FULLY CHARGED TO CLEAR THE POR. THE PATIENT REPORTED ON 2013-02-27 THE STIMULATION WAS UNCOMFORTABLE AND WANTED TO TURN IT OFF.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND AN EXPLANT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS REPROGRAMMING DONE AS PART OF TROUBLESHOOTING. THE PATIENT HAD BEEN REPROGRAMMED MULTIPLE TIMES WITH NO IMPROVEMENTS. THEY WANTED STIMULATION OUT SO THAT THEY COULD GET MRI AND CONSIDER THE NEED FOR SURGERY. ON (B)(6) 2015 IT WAS NOTED THAT THE SURGERY WAS CANCELLED AS SHE DID NOT STOP TAKING A CERTAIN MEDICATION. THEY DID NOT HAVE A RESCHEDULE DATE AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116351 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention