BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2911682 · Received January 11, 2013

    Report

    Report Number
    3004209178-2013-00491
    Event Type
    Injury
    Date Received
    January 11, 2013
    Report Date
    December 19, 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, 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 37092 LOT# 282090001, IMPLANTED: 2011 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THERE WERE PROBLEMS WITH COUPLING DURING RECHARGING. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IN OVERDISCHARGE. IT WAS STATED, THE LAST SUCCESSFUL RECHARGING SESSION WAS 4 MONTHS AGO. IT WAS INDICATED, THE INS WAS CLOSE TO THE SURFACE OF THE SKIN, BUT THE INS FELT "SLIGHTLY TILTED IN THE POCKET." WHEN USING THE ANTENNA LOCATE FEATURE, THE RECHARGER DISPLAYED A POWER ON RESET (POR) NOTIFICATION. THIS LED TO THE NORMAL RECHARGING SCREEN. TWO DAYS LATER, IT WAS REPORTED THAT A SUCCESSFUL PHYSICIAN MODE RECHARGE HAD BEEN PERFORMED. IT WAS NOTED, THE PATIENT HAD LOSS OF STIMULATION AND LESS PAIN RELIEF AS SYMPTOMS. IT WAS STATED, THE PATIENT WOULD BE SCHEDULED FOR A POCKET REVISION TO FIX THE "BATTERY ON A 45 DEGREE ANGLE." THE PATIENT WAS ABLE TO COUPLE THE RECHARGER AND INS, BUT ONLY WITH ASSISTANCE FROM THE MANUFACTURER REPRESENTATIVE. COUPLING WAS STATED AS BEING "VERY DIFFICULT." NO PATIENT OUTCOME WAS REPORTED AS THE PATIENT WAS "ONLY CHARGING FOR NOW, TO KEEP THE BATTERY FULLY CHARGED UNTIL THE REVISION HAPPENED." NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16658 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 Required Intervention