BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3061297 · Received April 16, 2013

    Report

    Report Number
    3004209178-2013-06344
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 29, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: 37746 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S STIMULATION WAS TURNING ON AND OFF. THE DEVICE WOULD "JOLT UP AND SHOCK" THE PATIENT AND THEN SHUT OFF. THE PATIENT WAS ASKED TO KEEP A DIARY. A COMPANY REPRESENTATIVE CONFIRMED THAT THE PATIENT WAS USING THE DEVICE CORRECTLY. THERE WAS NO PATTERN TO THESE INSTANCES, AND COULD OCCUR UP TO 15 TIMES PER DAY. IMPEDANCE MEASUREMENTS WERE NORMAL. ONE ELECTRODE WAS AT 276 OHMS. ADAPTIVE STIMULATION WAS ON AND APPEARED TO BE WORKING CORRECTLY. THE PATIENT HAD LET THE DEVICE GO TO DISCHARGE ONCE, ON (B)(6) 2013, BUT NO OTHER ISSUES NOTED. THE DIARY WAS TO BE REVIEWED, BUT NO FEEDBACK HAD BEEN PROVIDED AS OF THE TIME OF THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED; IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT. 2013 (B)(6). IT WAS FURTHER REPORTED THAT THE DATA FROM THE PROGRAMMER WAS SENT TO TECH SUPPORT. THE REP WAS TOLD IT COULD TAKE UP TO 3 DAYS FOR FURTHER INFO.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT EXPERIENCED HER STIMULATION TURNING OFF WITH "ALMOST EVERY MOVEMENT - WHEN SHE SAT UP, STOOD UP, WHEN IN HER CAR AND MADE TURNS, ETC." IT WAS RECOMMENDED THE PATIENT TURN HER STIMULATION OFF. IT WAS ALSO STATED THE PATIENT'S PHYSICIAN "WOULD PROBABLY BE REPLACING THE DEVICE." AT THE TIME OF REPORT IT WAS UNCONFIRMED WHETHER THE DEVICE WOULD ACTUALLY BE REPLACED. ADDITIONAL INFORMATION STATED IN THE PATIENT¿S HANDWRITTEN DIARY THAT THE ¿INS APPEARED TO BE ON FOR THE ENTIRE DAY ((B)(6) 2013) WITH NO INTERROGATIONS.¿ IT WAS ADDITIONALLY STATED THE IMPEDANCES ¿LOOKED NORMAL.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162825 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1