BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3458034 · Received November 8, 2013

    Report

    Report Number
    3004209178-2013-20444
    Event Type
    Malfunction
    Date Received
    November 8, 2013
    Report Date
    October 21, 2013
    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 37742, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3998, LOT# V012238, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3998, LOT# V012238, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER. PRODUCT ID 3998, LOT# J0555274V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING THE DEVICE OR THERAPY AND HAD NOT SOUGHT FURTHER HELP.

    Description of Event or Problem · 1

    THE PATIENT¿S MACHINE WAS NOT WORKING. HE USED TO GET RESIDUAL PAIN WHEN TURNING STIMULATION OFF AND NOW HE FEELS IT WITH STIMULATION ON. HE FEELS LIKE AN ELECTRICAL CURRENT AND HE NEEDS TO KEEP STIMULATION LOWER THAN PREVIOUSLY. THIS CHANGE OCCURRED A FEW MONTHS AGO AND THERE HAVE BEEN NO EVENTS, FALLS OR TRAUMAS. HE WAS DISSATISFIED WITH HIS HEALTH CARE PROFESSIONAL (HCP) AND DID NOT WANT TO INVOLVE HIS DOCTOR WITH THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579935 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 00064 YR