BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2575422 · Received May 15, 2012

    Report

    Report Number
    3004209178-2012-03317
    Event Type
    Injury
    Date Received
    May 15, 2012
    Report Date
    April 19, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3487A-33, LOT # V005313, IMPLANTED: (B)(6) 2006, EXPLANTED: NA; LEAD MODEL 3487A-33, LOT # V002794, IMPLANTED: (B)(6) 2006, EXPLANTED: NA; EXTENSION MODEL 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2011; EXTENSION MODEL 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2011; PROGRAMMER MODEL 37742, SERIAL # (B)(4); RECHARGER MODEL 37752, SERIAL # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PAIN RELIEF WAS INADEQUATE. THE PATIENT WORKED WITH HER HCP FOR SIX MONTHS TRYING TO REPROGRAM HER DEVICE. THE HCP TOOK AN X-RAY OF THE SYSTEM AND DETERMINED THAT "THE LEADS WERE DESTROYED" AND "THEY WEREN'T CONNECTING", AND THE PATIENT UNDERWENT A REPLACEMENT SURGERY. THE MANUFACTURER'S DEVICE REGISTRY SHOWED THAT THE PATIENT'S NEUROSTIMULATOR AND EXTENSION WERE REPLACED, WHILE THE LEADS WERE LEFT IN PLACE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention