BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3999821 · Received August 11, 2014

    Report

    Report Number
    3004209178-2014-15126
    Event Type
    Malfunction
    Date Received
    August 11, 2014
    Report Date
    July 18, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3487A-56, LOT# V235029, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3888-45, LOT# V284950, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3888-33, LOT# V287550, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3487A-56, LOT# V062324, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TRIPPED OVER THEIR DOG, FELL, AND LOST STIMULATION. THE PATIENT COULD NOT FEEL STIMULATION AT THE MAXIMUM OUTPUT. THERE WAS A LOSS OF THERAPEUTIC EFFECT, NOTED TO BE LESS THAN 50% THERAPY RELIEF. IMPEDANCE TESTING SHOWED ELECTRODES 2, 4, 5 AND 7 GREATER THAN 10,000 OHMS. THE DEVICE WAS REPROGRAMMED AVOIDING THESE ELECTRODES AND COVERAGE WAS REGAINED. THE PATIENT¿S STATUS WAS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477235 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1