BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3011290 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03924
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 28, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT WAS UNABLE TO ACHIEVE TELEMETRY BETWEEN THE DEVICE AND HIS PATIENT PROGRAMMER OR THE PHYSICIAN PROGRAMMER. A POWER ON RESET (POR) CONDITION WAS ALSO REPORTED. IT WAS REPORTED THE PATIENT EXPERIENCED AN OVERDISCHARGE. IT WAS NOTED THE PATIENT EXPERIENCED A ¿LOSS OF STIMULATION DUE TO OVERDISCHARGE.¿ IT WAS REPORTED THAT A PHYSICIAN MODE RECHARGE (PMR) WAS PERFORMED BY THE PATIENT¿S PHYSICIAN.

    Description of Event or Problem · 1

    ADDTIONAL INFORMATION REPORTED THE PATIENT'S IMPLANT WAS "KIND OF CAUGHT" AND IT WAS "UP ON THE BACK OF THEIR RIBS."

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE PATIENT'S RECHARGER WAS UNABLE TO READ HIS IMPLANTABLE NEUROSTIMULATOR (INS) AFTER GETTING UP TO ANSWER THE DOOR WHILE HE WAS CHARGING. IT WAS STATED THAT THE PATIENT WAS UNABLE TO HAVE THE PROGRAMMER READ THE INS WITH OR WITHOUT THE ANTENNA. IT WAS LATER REPORTED ON (B)(6) 2013 THAT AFTER IMPLANT "A WHILE AGO", THE PATIENT FELL BACKWARDS AND "HIT HIS BACK." IT WAS STATED THAT THE LAST CHARGING SESSION WAS ON (B)(6) 2013 AND HIS INS WAS ¾ FULL AND THAT WAS THE LAST TIME HE FELT STIMULATION. IT WAS STATED THAT THE PATIENT WAS NOT FEELING STIMULATION AT THE TIME OF REPORT. IT WAS NOTED BY THE PATIENT THAT HE USUALLY CHARGED ONCE A WEEK AND USUALLY GOT "4 BOXES, OR LESS IF HE MOVED." THE PATIENT ALSO STATED HE HAD STIMULATION ON DURING THE DAY AND OFF IN THE NIGHT. IT WAS ALSO NOTED THAT THE INS MOVED TO THE "BACK OF RIBS." REPORTEDLY THE PATIENT WAS STILL UNABLE TO GET COMMUNICATION BETWEEN THE PROGRAMMER AND INS, AND HAD UNSUCCESSFULLY TRIED THE ANTENNA LOCATE FEATURE THREE TIMES. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER AND IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113913 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 00048 YR