BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3980047 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13953
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 10, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377860, LOT# V010451, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER; PRODUCT ID 355029, LOT# N094926, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: ACCESSORY; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE HAD QUIT WORKING AND HADN¿T WORKED IN A COUPLE OF YEARS. THE DEVICE WAS STARTING TO BOTHER THE PATIENT. THE BATTERY WENT DEAD AND WOULDN¿T RECHARGE AND IT HAD GOTTEN TO THE POINT WHERE IT WAS HURTING THE PATIENT¿S BACK WHEN THEY LEANED ON IT OR TOUCHED IT JUST RIGHT. THE PATIENT WAS THINKING ABOUT HAVING THEIR DEVICE REMOVED BECAUSE THEY FIGURED IT HAD GONE BAD. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD TO HAVE THEIR DEVICE JUMPSTARTED ONCE PRIOR TO THE REPORT. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457740 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