BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 3734693 · Received April 8, 2014

    Report

    Report Number
    3004209178-2014-05817
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    November 1, 2013
    Report Date
    March 17, 2014
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 377760, LOT# V004017, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377760, LOT# V004017, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A FIRST OVER-DISCHARGE WAS CONFIRMED. IT WAS REPORTED THAT AN INITIAL PHYSICIAN MODE RESET (PMR) DID NOT SUCCESSFULLY RESET THE DEVICE. IT WAS FURTHER REPORTED THE PATIENT IS SCHEDULED FOR A FOLLOW-UP APPOINTMENT ON (B)(6) 2014. IT WAS NOTED THAT DUE TO THE DEVICE¿S AGE THE PATIENT WAS ALSO GOING TO DISCUSS POTENTIAL REPLACEMENT WITH THEIR HEALTH CARE PROVIDER (HCP). IT WAS REPORTED THAT THE REASON FOR OVER-DISCHARGE WAS THAT THE PATIENT HAD NOT USED THEIR DEVICE IN THE ¿PAST COUPLE OF MONTHS¿ DUE TO FAMILY ISSUES. IT WAS NOTED WHEN THE PATIENT TRIED TO RECHARGED THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ¿DEAD¿. IT WAS NOTED A TRICKLE DOWN CHARGE STARTED A REGULAR CHARGING SESSION AFTER SIXTY MINUTES AND THE PATIENT RECHARGED THE DEVICE. IT WAS NOTED THE APPOINTMENT ON 2014-03-19 WILL ALSO BE USED TO CLEAR THE POWER ON RESET (POR) AND REPROGRAMMING IF NEEDED. ADDITIONAL INFORMATION RECEIVED REPORTED A ¿0X8¿ ERROR CODE ACCOMPANIED THE POWER ON RESET (POR) MESSAGE. IT WAS REPORTED THAT DUE TO THE OVER-DISCHARGE THE PATIENT HAD A RETURN OF NECK AND LOWER JAW PAIN. IT WAS NOTED THAT THE POR WAS CLEARED AND AN IMPEDANCE CHECK WAS PERFORMED. THE RESULTS FROM THE IMPEDANCE CHECK SHOWED ELECTRODES 0,1,1 WERE ALL >3600 ¿BUT THIS MUST HAVE BEEN AN EXISTING CONDITION BECAUSE NONE OF THE PREVIOUS PROGRAMS INCORPORATED USE OF ANY THREE OF THESE ELECTRODES¿. IT WAS FURTHER REPORTED THE PATIENT WAS INSTRUCTED TO RECHARGE THEIR DEVICE TO 100% AND THEN TURN STIMULATION ON. IT WAS NOTED THE DEVICE IS 8 YEARS OLD AND REPLACEMENT WAS DISCUSSED HOWEVER THE PATIENT WISHED TO WAIT UNTIL A LATER DATE IN 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210655 TBD STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711AA

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR