BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3082139 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-06986
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 23, 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE TELEMETRY ISSUES. IT WAS STATED THAT AN OVERDISCHARGE WAS SUSPECTED AS THE LAST TIME "ANY" STIMULATION WAS FELT WAS "OVER 2 YEARS." IT WAS NOTED THAT "A COUPLE" PHYSICIAN MODE RECHARGES WERE PERFORMED, WITH NO SIGN OF POWER ON RESET OR NORMAL RECHARGING. IT WAS LATER REPORTED THAT THE OVERDISCHARGE WAS CONFIRMED. IT WAS STATED THAT THE MANUFACTURER REPRESENTATIVE WAS SCHEDULED TO MEET WITH THE PATIENT THE FOLLOWING WEEK TO TAKE THE DEVICE OUT OF OVERDISCHARGE STATE. IT WAS NOTED THAT THE PATIENT WAS "NOT EXPERIENCING ANY PAIN." IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS IN OVER DISCHARGE DUE TO BEING TURNED OFF FOR OVER A YEAR, AND NOT RECHARGED. THE PATIENT WAS GOING TO MAKE PLANS TO BRING THE DEVICE OF THE POWER-ON-RESET (POR) CONDITION THE FOLLOWING MONTH. IT WAS REPORTED THAT THERE WERE TELEMETRY ISSUES. IT WAS REPORTED THAT THEY WERE ABLE TO CLEAR THE POR,BUT THE BATTERY WAS UNABLE TO HOLD A CHARGE. IT WAS STATED THAT THE PATIENT DID NOT WANT TO COMMIT TO CHARGING BECAUSE THE STIMULATION DID NOT HELP WITH HER PAIN.

    Description of Event or Problem · 1

    IT HAD BEEN REPORTED THAT PATIENT HAD SEEN ERROR MESSAGE INDICATING THEY NEEDED TO REPOSITION THEIR DEVICE. IT WAS ALSO REPORTED THAT AFTER BATTERY HAD BEEN OVERDISCHARGED, THE BATTERY WAS UNABLE TO HOLD A CHARGE. IT WAS STATED THAT THE PATIENT DID NOT WANT TO COMMIT TO CHARGING BECAUSE THE STIMULATION DID NOT HELP WITH HER PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184538 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1