BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2863497 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11335
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 14, 2012
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377860, LOT# V008334, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 377860,, LOT# V008334, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THE PATIENT WAS CHARGING MORE THAN SHE EXPECTED. THE PATIENT STATED SHE HAD BEEN RECHARGING ON THE DAY OF THE REPORT SINCE "10 AM" AND THE DEVICE BATTERY ICON WAS NOT ADVANCING. IT THEN BEGAN TO ADVANCE DURING THE REPORT, LEADING THE PATIENT TO BELIEVE THE ANTENNA MOVED WHILE SHE WAS SLEEPING BECAUSE THAT WAS WHEN SHE NORMALLY CHARGED. ON (B)(6) 2012, IT WAS REPORTED THAT THE PATIENT STILL HAD RECHARGING ISSUES. THE PATIENT STATED SHE WAS RECHARGING EVERY "EIGHT HOURS". IT WAS NOTED THAT THE PATIENT SOMETIMES MAXED OUT HER AMPLITUDE AND TWO WEEKS PRIOR TO THE REPORT THE PATIENT HAD HER UPPER LIMIT INCREASED. THE PATIENT DID NOT COMPLAIN OF RECHARGING ISSUES AT THE TIME AND IMPEDANCES WERE NORMAL. THE PATIENT STATED SHE HAD AN OVERDISCHARGE EVENT, BUT THERE WAS NO CLEAR EVIDENCE BESIDES A POWER ON RESET (POR) MESSAGE IN A 2011 REPORT. A LONGEVITY CALCULATION WAS MADE USING THE PATIENT'S MAXED SETTINGS AND THE ESTIMATE WAS DEPLETION AFTER FOUR AND A HALF DAYS. THE PATIENT MAY HAVE BEEN "OVERSTATING" HER RECHARGING ISSUES BECAUSE SHE WANTED A NEW DEVICE. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2012, REPORTED THAT THE PATIENT HAD A REVISION THE WEEK PRIOR TO THE REPORT. THE DEVICE AND EXTENSION WERE REPLACED. PLEASE SEE MANUFACTURING REPORT #3004209178-2012-05801 FOR RELATED EVENT. THE PATIENT HAD BROKEN HER WIRES BEFORE AFTER A FALL, WHICH COULD HAVE CAUSED RECHARGING ISSUES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention