BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2804829 · Received October 25, 2012

    Report

    Report Number
    3004209178-2012-09545
    Event Type
    Injury
    Date Received
    October 25, 2012
    Report Date
    September 27, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 748925 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3987A LOT# N183268, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID, 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6),: PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708320 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LET HIS BATTERY DEPLETE AND IT WAS NOT ABLE TO BE RESTARTED WITH THE TRICKLE CHARGE PROCESS. IT WAS STATED THAT THE PATIENT LET THE BATTERY DEPLETE BEFORE, BUT THERE WERE NO RECORDS AT THE PHYSICIAN'S OFFICE INDICATING HOW MANY TIMES THAT OCCURRED. THE OLD BATTERY WAS REPLACED, AND IT WAS STATED THAT THE PATIENT IS NOW "DOING FINE". NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN IN OVERDISCHARGE FOR APPROXIMATELY FOUR MONTHS. A PMR (PHYSICIAN MODE RESET) SESSION WAS DONE A FEW DAYS AGO WITH NO LUCK AND ONE WAS DONE TODAY WITHOUT NORMAL COMMUNICATION BEING ESTABLISHED. SUBSEQUENT INFORMATION RECEIVED REPORTED THAT THE BATTERY COULD NOT BE REVIVED OUT OF OVERDISCHARGE. A DEVICE REVISION WAS BEING DONE TODAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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