BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3180213 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-10645
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: 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 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (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 WAS A POWER-ON-RESET (POR) CONDITION WITH ERROR CODE 0X3608. IT WAS NOTED THAT THIS WAS NOT A KNOWN ERROR CODE. IT WAS NOTED THAT MULTIPLE POR¿S WERE SUSPECTED TO HAVE OCCURRED. IT WAS NOTED THAT IT WAS INITIALLY STATED THAT THIS WAS THE THIRD OVERDISCHARGE. HOWEVER, IT WAS POSSIBLE TO BYPASS THE POR ERROR CODE ON THE PHYSICIAN PROGRAMMER AND NO END-OF-SERVICE (EOS) WAS DISPLAYED. IT WAS SURMISED THAT THIS WAS THUS THE SECOND OVERDISCHARGE AND NOT THE THIRD. IT WAS NOTED THAT THE FIRST OVERDISCHARGE OCCURRED AROUND THREE TO FOUR MONTHS AGO. A PHYSICIAN-MODE-RESET WAS PERFORMED TODAY AND AN ATTEMPT WAS MADE TO CLEAR THE 3608 ERROR CODE. IT WAS DISCUSSED THAT IT WAS DIFFICULT TO DETERMINE BATTERY DAMAGE, BUT THAT THE RECHARGE INTERVAL COULD BE 50-75% LESS THAN A NEW STIMULATOR. THE POTENTIAL FOR ANOTHER OVERDISCHARGE WAS NOTED. THE IMPLANTABLE NEUROSTIMULATOR WAS IMPLANTED ON THE PATIENT¿S RIGHT SIDE AND THAT THE PATIENT HAD LIMITED USE AND REACH WITH HIS RIGHT ARM. THE PATIENT HAD BEEN UNABLE TO RECHARGE WITHOUT ASSISTANCE. IT WAS NOTED THAT THE PATIENT HAD NOT HAD ANYONE AROUND TO ASSIST RECHARGING. THERE WAS A PLAN TO MOVE THE BATTERY TO THE LEFT BUTTOCK SO THE PATIENT COULD CHARGE MORE EASILY.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THERE WERE NO MALFUNCTIONS. THE STIMULATOR WAS RECOVERED AND WAS FUNCTIONING CORRECTLY. THE PATIENT WAS DOING FINE AND STIMUALTION WAS EFFECTIVE. NO FURTHER INFORMATION ON MOVING THE STIMULATOR WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281196 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 00050 YR Required Intervention