BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3175495 · Received June 18, 2013

    Report

    Report Number
    3004209178-2013-10526
    Event Type
    Injury
    Date Received
    June 18, 2013
    Date of Event
    December 17, 2012
    Report Date
    May 28, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3550-29 LOT# N250164, IMPLANTED: 2010 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID 3777-45 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6),EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 3708120 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD THEIR STIMULATOR REMOVED (B)(6) 2012. IT WAS NOTED, THE DEVICE WAS REMOVED BECAUSE ¿IT CAUSED SCAR TISSUE AROUND THE SPINAL CORD.¿ FOLLOW UP FROM THE HEALTH CARE PROFESSIONAL REVEALED THE CAUSE OF THE EVENT WAS DUE TO THE FORMATION OF A GRANULOMA AROUND THE TOP OF THE LEAD CAUSING CORD COMPRESSION AND DISPLACEMENT. SIGNS AND SYMPTOMS ASSOCIATED WITH THE EVENT INCLUDE WEAKNESS IN LEGS AND THORACIC PAIN. THE PATIENT REQUIRED HOSPITALIZATION DUE TO THE EVENT. IT WAS NOTED, THE PATIENT RECOVERED WITHOUT SEQUELA. IT WAS NOTED THE ENTIRE SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275783 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 00059 YR Hospitalization| R