BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3246824 · Received July 25, 2013

    Report

    Report Number
    3004209178-2013-12284
    Event Type
    Injury
    Date Received
    July 25, 2013
    Report Date
    May 20, 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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 3708240 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3776-45 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3550-39 LOT# N168183, IMPLANTED: 2009 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID 3550-39 LOT# N202073, IMPLANTED: 2009 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID 3487A-45 LOT# V121707, IMPLANTED: 2009 (B)(6), EXPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3487A-45 LOT# V191307, IMPLANTED: 2009 (B)(6), EXPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ATTORNEY ALLEGED THAT THE PATIENT SUSTAINED SERIOUS PERSONAL INJURIES FOLLOWING THE FAILURE OF A SPINAL STIMULATOR. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348521 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 Other| R