BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3981554 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13980
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 11, 2014
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37744, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    WHEN CONTACTED FOR FOLLOW UP INFORMATION THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THEY HAD NOT SEEN THE PATIENT (NOR ANYONE ELSE IN THEIR OFFICE) SINCE (B)(6) 2014 AND HAD NO KNOWLEDGE OF THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WANTED TO DONATE HIS EXTERNAL COMPONENTS. THE DEVICE STOPPED WORKING AND WAS NOT EFFECTIVE. ONE TIME THE DEVICE FAILED RIGHT IN FRONT OF A COMPANY REPRESENTATIVE BUT THEY SAID IT WAS WORKING. THE DEVICES WERE REMOVED ABOUT 1.5 WEEKS AGO AND WAS REPLACED WITH A COMPETITOR DEVICE. THE PATIENT HAS 2 ¿REMOTES¿ AND 2 CHARGERS TO DONATE. IT WAS FURTHER REPORTED THAT THE DOCTOR PUT THE DEVICE IN THE WRONG PLACE. IT WAS SUPPOSED TO BE PUT IN AT DISC T10/T11 AND ENDED UP PUTTING IT AT L5 WHICH WAS THE WRONG LOCATION. THE PAIN MANAGEMENT DOCTOR INSTRUCTED HIM TO PUT IT THERE. THE PATIENT WAS BASICALLY NOT EVEN USING IT. THE DEVICE WAS REMOVED ON (B)(6) 2014 BECAUSE, THE BATTERY WENT DEAD AND COULD NOT GET IT GOING AGAIN. THE DEVICE LET THE PATIENT DOWN AND HE HAD TOO MANY PROBLEMS WITH IT. THE PATIENT HAD TO GO OUT OF TOWN AND HE DID NOT TAKE HIS RECHARGER WITH HIM. THE PATIENT WAS ONLY SUPPOSED TO BE GONE FOR 1 DAY BUT ENDED UP STAYING LONGER. THE BATTERY WENT DEAD AND IT WOULD NOT WORK AFTER THAT. THE COMPANY REPRESENTATIVE REPORTED THAT THEY ONLY MET WITH THE PATIENT ONCE AND HIS BATTERY WAS CHARGING PROPERLY AND WAS GETTING SUFFICIENT COVERAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456626 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 00069 YR Required Intervention