BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3213750 · Received July 9, 2013

    Report

    Report Number
    3004209178-2013-11501
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 20, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4): PRODUCT TYPE RECHARGER; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012: PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012: PRODUCT TYPE LEAD; PRODUCT ID 3550-39, LOT# N345204, IMPLANTED: (B)(6) 2012: PRODUCT TYPE ACCESSORY; PRODUCT ID 355531, LOT # N347326, IMPLANTED: (B)(6) 2012: PRODUCT TYPE SCREENING DEVICE; PRODUCT ID 37744, SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID 37744, SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    THE HEALTH CARE PROVIDER CONFIRMED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. NO HOSPITALIZATION WAS REQUIRED. THE PATIENT OUTCOME WAS NOTED AS NO INJURY.

    Description of Event or Problem · 1

    (B)(6) 2013, (B)(4): IT WAS REPORTED THAT THE PATIENT COULD NOT GET THEIR BATTERY TO CHARGE. THE BATTERY RAN OUT ABOUT NOON THE DAY PRIOR TO THIS REPORT. THE PATIENT HAD NO STIMULATION. THE RECHARGER SCREEN DISPLAYED A BATTERY THAT WAS DESCRIBED AS THE RECHARGER BATTERY. THE PLUG ICON WAS VISIBLE WHEN THE RECHARGER WAS PLUGGED INTO THE WALL. THE RECHARGER BATTERY APPEARED FULL. RECHARGER WOULD BEEP 3 TIMES AND SHOW A "REPOSITION ANTENNA" SCREEN. PATIENT USED PATIENT PROGRAMMER AND WAS ABLE TO SYNC AND SEE APPROPRIATE PROGRAMMING BUT PATIENT DID NOT SEE A BATTERY INDICATOR EVEN THOUGH THERE WAS SPACE WHERE IT SHOULD HAVE BEEN. THE PATIENT HAD NOT SEEN ANY LOW BATTERY INDICATORS. THE PATIENT NOTICED THE PROBLEM AFTER FALLING ASLEEP WITH THE DEVICE ON. A NEW RECHARGER WAS NEEDED. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THERE WAS A CALL YOUR DOCTOR ICON DISPLAYED. A POWER ON RESET (POR) CONDITION OCCURRED. THE PATIENT GOT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) FULLY CHARGED EARLIER WHEN THEY MEET WITH A MANUFACTURING REPRESENTATIVE. THE PATIENT WAS SEEING A POR WARNING MESSAGE. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313879 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR