BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3590005 · Received January 23, 2014

    Report

    Report Number
    3004209178-2014-01076
    Event Type
    Malfunction
    Date Received
    January 23, 2014
    Date of Event
    December 17, 2013
    Report Date
    December 27, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER STATED THAT A COMPANY REPRESENTATIVE MET WITH THE PATIENT. THE BATTERY WAS OVERDSICHARGED. HER PHYSICIAN INSTRUCTED HER ON HOW TO RESET IT AND CHARGE IT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED ON (B)(6) 2014 THAT SHE RECEIVED ASSISTANCE FROM HER DOCTOR OR COMPANY REPRESENTATIVE AND HER CONCERNS WERE RESOLVED. AN APPOINTMENT DATE OF (B)(6) 2014 AT 12:15PM WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NO STIMULATION SENSATION. IT WAS REPORTED THE PATIENT HAD BEEN BEATEN UP BY HER HUSBAND ON (B)(6) 2013 AND HER STIMULATOR (INS) STOPPED WORKING. IT WAS NOTED THE PATIENT WAS DRAGGED ACROSS THE ROOMS ON HER SIDE AND STATED "I 'DNK' IF HE PULLED MY WIRES LOOSE". THE PATIENT STOPPED FEELING STIMULATION IN HER LEGS AFTER THE EVENT AND WAS HOSPITALIZED. THE PATIENT WAS THEN GETTING OUT OF THE HOSPITAL AND COLLAPSED. THE PATIENT WAS WALKING WITH HER CANE AGAIN AND DID NOT FEEL ANY STIMULATION. IT WAS REPORTED THE PATIENT WAS STILL SORE AND THE BRUISING WAS JUST GOING AWAY, SHE ACHED ALL OVER AND COULD NOT TELL IF THERE WAS ANY PAIN AROUND THE LEADS. IT WAS LATER REPORTED THE PATIENT HAD NOT BEEN ABLE TO CHARGER HER INS. IT WAS REPORTED THE PATIENT TRIED TO CHARGE ON (B)(6) 2013 AND THE "BATTERY GOT OVERHEATED AND IT WAS NOT WORKING". IT WAS NOTED THE PATIENT THOUGHT THE BATTERY INSIDE OF HER GOT HOT, AND REPORTED FEELING IT ONLY DURING THE CHARGING SESSIONS. IT WAS REPORTED THE PATIENT DID NO SEE ANY MESSAGE SCREENS, ONLY THAT HER RECHARGER (INSR) SHOWED HER INS WAS "DEAD". THE INS WILL GET HOT AND WILL NOT CHARGE. THE INS HAD NOT BEEN ABLE TO CHARGE SINCE (B)(6) 2013. IT WAS NOTED THE PATIENT RECHARGES ABOUT ONCE A MONTH AND LAST TIME THE PATIENT CHARGED WAS LAST MONTH. IT WAS NOTED THE PATIENTS PROGRAMMER SHOWED THE INS BATTERY WAS LOW. NO NEW REPORTABLE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54144 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 00056 YR