BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3980003 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13952
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 16, 2012
    Report Date
    July 16, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7495LZ25, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 7495LZ25, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-33, LOT # J0313988V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT # J0313988V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT NEEDS THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED BECAUSE IT WAS OVER-DISCHARGED AND THE MANUFACTURER REPRESENTATIVE COULD NOT GET THE BATTERY GOING AGAIN. IT WAS REPORTED NO REPLACEMENT HAS BEEN SCHEDULED OR PLANNED AS THE HEALTH CARE PROVIDER (HCP) OFFICE IS ¿DRAGGING THEIR FEET¿. IT WAS NOTED THE PATIENT HAS TRIED A COUPLE TIMES TO RECHARGE AND THEY COULD NOT GET IT GOING. IT WAS FURTHER REPORTED THE OVER-DISCHARGE OCCURRED APPROXIMATELY 3-6 MONTHS PRIOR TO REPORT. IT WAS FURTHER NOTED THAT THE PATIENT HAS HAD RECHARGING ISSUES FOR A COUPLE YEARS NOW STATING THAT THEY COULD NOT GET THE DEVICE TO FULLY RECHARGE. IT WAS NOTED IT WOULD ¿SAY IT WAS FULL BUT THE METER (PATIENT PROGRAMMER) SAID IT WAS ONLY HALF WAY¿. INFORMATION OMITTED PERTAINING TO EVENT (B)(4) ¿ PAIN AT IMPLANT SITE. THESE EVENTS ARE NOT RELATED. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT STILL HAS CONCERNS WITH THEIR DEVICE OR THERAPY AND IS MEETING WITH THEIR HEALTH CARE PROVIDER (HCP) OR MANUFACTURER REPRESENTATIVE ON (B)(4) 2014. A PHONE CALL TO THE PATIENT'S HCP CONFIRMED THE PATIENT WAS SEEN ON (B)(6) 2014 AND MINOR REPROGRAMMING MAY HAVE BEEN PERFORMED. THE PATIENT CALLS INTO THEIR CLINIC ¿ONCE IN A WHILE¿ TO ASK THAT THE BATTERY BE REPLACED DUE TO IT NOT HOLDING A CHARGE. CONFIRMATION OF THE PATIENT¿S APPOINTMENT FOR (B)(6) 2014 WAS MADE AND IT WAS NOTED IT WAS SIMPLY FOR FOLLOW UP AND NOT REVISION. A PHONE CALL TO THE PATIENT'S MANUFACTURER REPRESENTATIVE STATED THEY WERE UNAWARE OF ANY OVERDISCHARGE OR OTHER INFORMATION REGARDING THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAS CONTINUED TO RESCHEDULE THEIR APPOINTMENTS AND HAS NOT BEEN SEEN SINCE (B)(6) 2014. IT WAS DETERMINED THE PATIENT NEEDED A NEW BATTERY DUE TO IT NOT HOLDING A CHARGE AND BECAUSE IT WOULD NOT TURN ON. THE REPLACEMENT HAS BEEN AUTHORIZED HOWEVER THE PATIENT HAS NOT RETURNED ANY CALLS TO THE HEALTH CARE PROVIDER (HCP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458314 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention