BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2925640 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00843
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    January 2, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR LAST TWO WEEKS A PATIENT HAD BEEN EXPERIENCING ISSUES WITH RECHARGING. THE ISSUE PERSISTED EVEN WITH "REPLACEMENT RECHARGER COMPONENTS." IT WAS STATED THAT THE PATIENT COULD ONLY CHARGE UP TO 75% AND AT THE TIME OF THE REPORT SHE COULD ONLY CHARGE UP TO 50% FULL. THIS STARTED TO OCCUR OVER THE LAST TWO WEEKS. THE PATIENT HAD ALWAYS HAD A RECHARGE INTERVAL OF 1 TO 1.5 DAYS, AND IT WAS STATED THAT THIS WAS IN LINE WITH HER PARAMETERS AND SETTINGS. IT WAS REPORTED THAT THE PATIENT USED PROGRAM GROUP D 90% OF TIME AND HAD STIMULATION ON 95% OF TIME. NO CYCLING WAS PROGRAMMED. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS SET AT 6.5V, 740US, 60HZ WITH ELECTRODES 1+, 2-, 3+, 6+, 7-, 8+, 12+, 13+, 14+. ELECTRODE IMPEDANCE TEST AT .7V SHOWED RESULTS IN RANGE OF 743 TO 1117 OHMS WHICH WAS STATED AS "INTACT." NO GROUP IMPEDANCES WERE AVAILABLE. NO REPROGRAMMING OR CHANGE IN SETTINGS OCCURRED OVER THE LAST TWO WEEKS. IT WAS STATED THAT AS OF THE LAST TWO WEEKS THE STIMULATION SENSATION RANDOMLY TURNED OFF AND "STIMULATION WAS ACTING WEIRD." EIGHT DAYS LATER, IT WAS ALSO REPORTED THAT THE PATIENT USED THE INS SYSTEM 24 HOURS PER DAY, AND HER PARAMETERS WERE HIGHER THAN NORMAL. AFTER SOME TROUBLESHOOTING, THE PATIENT WAS STILL EXPERIENCING THE ISSUE OF THE INS NOT CHARGING TO 100%, AND SHE WAS HAVING TO CHARGE HER SYSTEM DAILY. IT WAS ALSO STATED THAT LONGEVITY CALCULATIONS HAD BEEN PERFORMED AND A REVISION HAD BEEN SCHEDULED FOR THE NEXT WEEK. 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 STATED THAT PREMATURE BATTERY DEPLETION WAS REPORTED AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED. IT WAS STATED PATIENT HAD SYMPTOMS OF PAIN AND PAIN CONTROL. PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29662 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Required Intervention