BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2830573 · Received November 13, 2012

    Report

    Report Number
    3004209178-2012-10203
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 16, 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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 39565-65 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. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS MODEL 37712 SERIAL (B)(4) FOUND THE BATTERY WAS AT END-OF-SERVICE DUE TO THREE OVERDISCHARGES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION. IT WAS STATED THAT THE PATIENT WENT ON VACATION AND FORGOT HIS RECHARGER. THE REPORTER STATED THAT STIMULATION WAS LAST FELT ON (B)(6) 2012. IT WAS REPORTED TWO DAYS LATER THAT THE DEVICE WAS AT END OF SERVICE (EOS). THE REPORTER STATED THE LAST STIMULATION WAS "QUITE A WHILE AGO." IT WAS STATED THAT THE PATIENT WAS RECHARGING THE DEVICE, BUT WAS UNABLE TO TURN STIMULATION ON DUE TO EOS. IT WAS NOTED THAT THE PATIENT HAD ONE OVERDISCHARGE EVENT IN THE PAST AND THAT THERE WAS ONLY ONE PHYSICIAN RECHARGE MODE CYCLE PERFORMED. HOWEVER, THE PATIENT DID NOT MEET WITH A PHYSICIAN TO RESET THE CLOCK ON THE DEVICE. THE REPORTER STATED, THE LAST RECHARGE DATE WAS (B)(6) 2010. IT WAS ALSO NOTED THAT THE IMPEDANCES WERE WITHIN NORMAL RANGE AND THAT STIMULATION COULD NOT BE TURNED ON. THE DAY AFTER THAT, IT WAS REPORTED THAT DURING THE PATIENT'S LAST APPOINTMENT IT WAS UNCLEAR IF THE BATTERY HAD NORMAL DEPLETION OR IF A MALFUNCTION WAS SUSPECTED. THE REPORTER ALSO STATED THAT IT WAS UNCLEAR IF THE LEAD WAS FUNCTIONING. THE PATIENT WAS TO BE SCHEDULED FOR A DEVICE REPLACEMENT AND POSSIBLE LEAD REVISION, BUT A DATE WAS NOT SET AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. ANY ADDITIONAL INFORMATION RECEIVED WOULD BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT COULD NOT CHARGE AND HAD NO STIMULATION. IT WAS NOT KNOWN HOW MANY RESETS THE PATIENT HAD ON THE DEVICE. THE INS WAS EXPLANTED AND REPLACED, AND IT WAS REPORTED THAT THE PATIENT RECOVERED WITHOUT SEQUELA.

    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 00050 YR Required Intervention