BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3926517 · Received July 10, 2014

    Report

    Report Number
    3004209178-2014-12800
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    January 1, 2012
    Report Date
    November 30, 2018
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL # (B)(4), IMPLANTED: (B)(4) 2010, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED AN IMPLANTABLE NEUROSTIMULATOR (INS) OVERDISCHARGE WAS SUSPECTED. THE DEVICE HAD REPORTEDLY NEVER BEEN IN THAT STATE (OF OVERDISCHARGE) BEFORE, PER THE PATIENT. THE LAST TIME ANY STIMULATION WAS FELT WAS OVER 12 MONTHS AGO. THE LAST SUCCESSFUL RECHARGING SESSION WAS OVER 12 MONTHS AGO. IT WAS NOTED THE PATIENT DIDN¿T HAVE THE PAIN FOR A WHILE. IT WAS REPORTED THE ¿WIRES WERE FLOATING EVERYTHING ELSE AND GETTING ZAPPED¿ AND THE DEVICE DIDN¿T TAKE A CHARGE ANYMORE. THE PATIENT REPORTEDLY TRIED FOR OVER 2 HOURS TO GET IT TO CHARGE AND CONNECT AND IT NEVER DID. THE PATIENT COULD HARDLY WALK. IT WAS NOTED THE WIRES WERE NOT EVEN ATTACHED ANYMORE. IT WAS NOTED THE PATIENT COULD FEEL ¿IT FLOATING IT AROUND¿ AND GOT CRAMPS IN HER BACK AND ¿HAD IT BEFORE AND COULD ALWAYS FEEL IT IN SAME SPOT¿ AND NOW THE WIRES DID NOT FEEL LIKE THEY WERE IN THE SAME SPOT. THE PATIENT HAD AN APPOINTMENT WITH THE HEALTH CARE PROVIDER (HCP) ON (B)(6) 2014 REGARDING THE STIMULATOR. THE PATIENT JUST WANTED SOMEONE TO ¿CALL THE DOCTOR AND TELL HIM WHO CAN TAKE OUT.¿ IT WAS NOTED THE HCP WAS GOING TO ¿TAKE OUT SOMETHING AND PUT SOMETHING IN FOR YOUR DISCS OR VERTEBRAE.¿ THE PATIENT WAS UNSURE WHAT THE HCP WAS GOING TO DO SURGICALLY FOR HER SPINE, BUT HAD NOT SEEN HIM IN 6 MONTHS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT HAD THEIR INS BATTERY REPLACED "THEY THINK IN 2015". NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403261 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention