BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2854635 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11061
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    November 6, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3776-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3776-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3550-39 LOT# N230415, IMPLANTED: 2010 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A COUPLING OR COMMUNICATION ISSUE AND AN IMPLANTABLE NEUROSTIMULATOR (INS) OVERDISCHARGE WAS SUSPECTED. IT WAS NOTED THAT DISSATISFACTION WITH STIMULATION WAS THE PRIMARY REASON FOR THE OVERDISCHARGE. THE PATIENT HAD REPORTEDLY BEEN FEELING A BURNING SENSATION AT THE INS POCKET STARTING 6 MONTHS AFTER IMPLANT. THE PATIENT "GOT TIRED OF FEELING THE BURNING" AND TURNED THE STIMULATION OFF. IT WAS ALSO NOTED THAT THE LAST TIME THE PATIENT FELT STIMULATION WAS 2 TO 6 MONTHS AGO. THE NEXT DAY, IT WAS REPORTED THAT THE DEVICE RECHARGER WAS NOT CHARGING. IT WAS THOUGHT THAT THERE WAS A CONNECTOR PIN BENT OR BROKEN. IT WAS FURTHER REPORTED THAT THE PATIENT HAD JUST HAND AN OVERDISCHARGE EVENT. THE BATTERY WAS SUCCESSFULLY BROUGHT OUT OF OVERDISCHARGE AND EVERYTHING WAS FUNCTIONING NORMALLY. IT WAS NOTED THAT THE PIN ON THE BACK OF THE CORD "JUST NEEDED TO BE REPLACED." THE FOLLOWING DAY, IT WAS REPORTED THAT THE PATIENT HAD STATED THAT SHE HAD MULTIPLE FALLS SINCE IMPLANT. X-RAYS WERE TAKEN OF THE LEADS AND DEVICE. IT WAS NOTED THAT THE ORIGINAL POSITION OF THE LEADS WAS UNKNOWN, BUT THE LEADS "COULD" HAVE MIGRATED AS THE LEADS WERE NOTICED TO BE STAGGERED. IT WAS FURTHER NOTED THAT THE LEFT LEAD WAS AT THE TOP OF THORACIC VERTEBRAE #7 AND THE RIGHT LEAD WAS AT THE TOP OF THORACIC VERTEBRAE #8. IMPEDANCES WERE CHECKED AFTER THE DEVICE WAS RECOVERED WITH A PHYSICIAN MODE RESET (PMR) AND WERE WITHIN NORMAL LIMITS. THE PRM WAS INITIATED ON (B)(4) 2012 AND THE DEVICE RECOVERED. THE PATIENT'S BATTERY WAS RECHARGED TO 100% CHARGE. IT WAS NOTED THAT THE PATIENT DID NOT FEEL ANY BURNING SENSATION WHILE RECHARGING. IT WAS FURTHER REPORTED THAT THE PATIENT WAS REPROGRAMMED AFTER THE DEVICE RECOVERED AND FULLY CHARGED, AND THE POWER ON RESET (POR) WAS CLEARED. THE PATIENT WAS REPORTEDLY INSTRUCTED TO "EXERCISE THE DEVICE" AND TO CONTINUE CHARGE AND MONITOR THE BATTERY. THE PATIENT WAS ALSO INSTRUCTED TO STOP ANY CHARGING IF ANY BURNING SENSATION OCCURRED AND TO FOLLOW UP IF ADDITIONAL REPROGRAMMING WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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