BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3202648 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11202
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 10, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3998, LOT# V077531, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY, BUT HAD NOT SOUGHT FURTHER HELP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) ¿QUIT WORKING¿ ABOUT THREE YEARS PRIOR TO THIS REPORT. IT WAS NOTED THE PATIENT RELOCATED TO (B)(6) FOR A ¿COUPLE YEARS¿ AND DID NOT HAVE THE ISSUE ADDRESSED. THE PATIENT HAD NOT CHARGED THE DEVICE AFTER IT ¿QUIT WORKING.¿ IT WAS NOTED THE DEVICE WOULD NOT RECHARGE. IT WAS NOTED THE INS WAS PLACED ON THE LEFT SIDE OF THE STOMACH FOR KNEE PAIN. IT WAS NOTED THE PATIENT BROKE RIBS ON THE RIGHT SIDE OF THE BODY THREE MONTHS PRIOR TO REPORT THIS REPORT. THE PATIENT NOTICED REDNESS, BURNING AND SORENESS AT THE INS LOCATION. IT WAS NOTED IT WAS WORSE IN THE MORNING. THE SYMPTOMS HAD BEEN PRESENT FOR TWO MONTHS PRIOR TO THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302197 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR