BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3111025 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07607
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    September 28, 2011
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3888-45, LOT # V482980, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT # V583004, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3776-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY, BUT WAS WORKING WITH THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S RECHARGER AND PROGRAMMER WERE NOT RESPONDING AND THE LAST TIME THE PATIENT CHARGED WAS SEVEN MONTHS PRIOR TO REPORT. IT WAS ALSO REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND STATED THEIR DEVICE ONLY PROVIDED RELIEF FOR THE FIRST SIX MONTHS. IT WAS NOTED THE PATIENT HAD A BAD FALL SIX MONTHS AFTER IMPLANT AND A MANUFACTURER REPRESENTATIVE "RESET" THEIR DEVICE. IT WAS STATED THE PATIENT'S DEVICE PROVIDED RELIEF FOR A MONTH AFTER IT WAS "RESET" BUT THEN THE PAIN CAME BACK. REPORTEDLY, THE PATIENT HAD BEEN CHARGING EVERY DAY. IT WAS STATED THE PATIENT WAS PRESCRIBED PAIN MEDICATION. THE PATIENT REPORTED THEY COULD FEEL THE "WIRES" STICKING OUT IN HER BACK AND THE IMPLANTABLE NEUROSTIMULATOR (INS) STUCK OUT, "LIKE IT WANTS TO COME OUT." REPORTEDLY, THE PATIENT'S PAIN AT THE TIME OF REPORT WAS WORSE THAN A FEW YEARS PRIOR TO REPORT. IT WAS STATED THE PATIENT WANTED TO HAVE THEIR DEVICE REMOVED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213286 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR