BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2402802 · Received January 6, 2012

    Report

    Report Number
    3004209178-2012-00133
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Date of Event
    December 15, 2011
    Report Date
    December 20, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3487A-56, LOT # V083355, IMPLANTED: (B)(6) 2008, EXPLANTED: NA; LEAD MODEL 3487A-56, LOT # V137815, IMPLANTED: (B)(6) 2008, EXPLANTED: NA; LEAD MODEL 3487A-56, LOT # V137815, IMPLANTED: (B)(6) 2008, EXPLANTED: NA; LEAD MODEL 3487A-56, LOT # V660847, IMPLANTED: (B)(6) 2011, EXPLANTED: NA; EXTENSION MODEL 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: NA; EXTENSION MODEL 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: NA; PROGRAMMER MODEL 337743, SERIAL # (B)(4); ACCESSORY MODEL 37752, SERIAL # (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCES ABOVE 10,000 OHMS WERE NOTED ON CONTACTS 8 AND 9. THERE WERE NO SIGNS OR SYMPTOMS RELATED TO THE EVENT, AND THE PATIENT WAS REPROGRAMMED ON (B)(6) 2011. THE OUTCOME WAS REPORTED AS ONGOING WITH NO FURTHER ACTION NEEDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION. THE PATIENT HAD LOSS OF STIMULATION PARESTHESIA IN THE LEFT LEG. IT WAS NOTED THE EVENT WAS RELATED TO THE DEVICE OR THERAPY, BUT NOT RELATED TO THE IMPLANT PROCEDURE. THE DEVICE WAS REPROGRAMMED AGAIN ON (B)(6)-2012, AND THE ISSUE RESOLVED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR