BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2882209 · Received December 20, 2012

    Report

    Report Number
    3004209178-2012-12101
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 30, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO ANOMALY. THE DEVICE WAS SET TO THE PARAMETERS THAT THE RETURNED DEVICE HAD WHEN IT WAS RECEIVED FOR ANALYSIS AND WAS FOUND TO FUNCTION PROPERLY FOR 100 HOURS AT BODY TEMPERATURE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS DISSATISFIED WITH THEIR IMPLANTABLE NEUROSTIMULATOR (INS). A LONGEVITY CALCULATION TO ESTIMATE BATTERY LIFE WAS DONE. LONGEVITY WAS 10 MONTHS FOR CURRENT SETTINGS, 19 MONTHS IF THEY USED 8 HOURS PER DAY AND 25 MONTHS WITH 8 HOURS PER DAY AND 60 HERTZ RATE. IT WAS NOTED THE INS WOULD BE CHANGED THE DAY OF THE REPORT DUE TO PATIENT BEING DISSATISFIED WITH THE INS. PATIENT SHOWED CHARGE SESSIONS IN MIDDLE OF SEPTEMBER, END OF SEPTEMBER, MIDDLE OF OCTOBER AND THE END OF NOVEMBER. DIARY ALSO CONTAINED NOTE THAT TIME AND DATE HAVE CHANGED. PATIENT NOTED THEY HAD SEEN "DOCTOR SCREEN" BUT COULDN'T RECALL LETTERS OR NUMBERS THAT WERE ON THE SCREEN. IT WAS ALSO NOTED THE STIMULATION WAS TURNING OFF AND ON. IT WAS NOTED THERE WAS A "SURGING SENSATION" AND A "FADING SENSATION." IT WAS ALSO NOTED THE STIMULATION THERAPY WORKED FINE INITIALLY BUT APPROXIMATELY 3 MONTHS AFTER IMPLANT PATIENT INDICATED STIMULATION WAS "SHUTTING OFF AND TURNING ON BY ITSELF." STIMULATION WAS ALSO "SURGING UP TO 10 VOLTS AND GOING DOWN TO 0 VOLTS." THE PATIENT HAD SEEN THE CHANGE IN VOLTAGE USING THEIR PATIENT PROGRAMMER, "EVEN THOUGH THE PATIENT HADN'T DONE ANYTHING TO CHANGE THE VOLTAGE." PATIENT PROGRAMMER HAD BEEN REPLACED BUT THE ISSUES CONTINUED. IT WAS NOTED THE PATIENT USED STIMULATION AS NEEDED. DIARY INDICATED THE ONLY DAY THE PATIENT USED STIMULATION WAS (B)(6) 2012. FOLLOW UP REPORTED IMPEDANCES WERE NORMAL. IT WAS NOTED THE REPROGRAMMING IN THE PAST HAD NOT CHANGED THE PATIENT'S PERCEPTION OF SUDDEN CHANGES IN STRENGTH. X-RAY REVEALED INTACT SYSTEM WITH NO CHANGE IN LEAD LOCATION. NO MALFUNCTIONS SEEN OR CAUSE OF ISSUE DETERMINED. AFTER REPLACEMENT OF DEVICE PATIENT WAS DOING "FINE." NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE STIMULATION WOULD SUDDENLY SURGE TO 10.5 VOLTS WITHOUT ANY COMMUNICATION WITH THE PATIENT PROGRAMMER, AND STIMULATION WOULD SPORADICALLY SHUT OFF. IT WAS NOTED THAT THERE WAS NOT NORMAL BATTERY DEPLETION. THERE WAS NO PATIENT INJURY, AND THE PATIENT RECOVERED WITHOUT SEQUELA. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention