BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3853818 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-10257
    Event Type
    Injury
    Date Received
    June 6, 2014
    Report Date
    May 19, 2014
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37712, SERIAL# (B)(4), IMPLANTED: (B)(6), 2010, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS SCHEDULED TO HAVE HER NECK SPINAL CORD STIMULATOR (SCS) REPLACED (B)(6) 2014 BECAUSE IT HAS NEVER KEPT A CHARGE. IT WAS NOTED THE PATIENT HAD TWO STIMULATION DEVICES, ONE FOR THE NECK AND ONE FOR THE LUMBAR REGION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332503 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 00061 YR Required Intervention