BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2674227 · Received July 30, 2012

    Report

    Report Number
    3004209178-2012-06236
    Event Type
    Injury
    Date Received
    July 30, 2012
    Report Date
    April 18, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT# V010366, SERIAL# IMPLANTED: (B)(6) 2006, EXPLANTED: PRODUCT TYPE LEAD. PRODUCT ID 37752, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: PRODUCT TYPE RECHARGER. PRODUCT ID 37742, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708240, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DID NOT WORK SINCE IMPLANT. THE DEVICE WAS PROGRAMMED MORE THAN SIX TIMES. THE PATIENT HAD MORE PAIN AFTER THE DEVICE WAS IMPLANTED. THE PATIENT FELT AS IF THE DEVICE WAS CAUSING MORE HARM. THE PATIENT HAD LUMBAR PAIN, WHICH WAS STATED TO BE DUE TO ARTHRITIS AND OSTEOPOROSIS. THE PATIENT COULD NOT BEND. THE PATIENT FELT A STABBING PAIN AROUND THE DEVICE; THE AREA AROUND IT WAS PURPLE, AND HAD BEEN SINCE IMPLANT. THE PATIENT WISHED TO HAVE THE DEVICE REMOVED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Other