BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2862453 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11317
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 15, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3888-56 LOT# V706699, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3888-33 LOT# V714493, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708220 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS ONLY GETTING "ABOUT 4 COUPLING BARS." ANTENNA LOCATE FEATURE WAS TRIED AND ABOUT 50% OF TELEMETRY WAS OBTAINED. IT WAS STATED, THE PATIENT USUALLY HAD 4 BARS AND HAD TRIED A DIFFERENT RECHARGER AND IMMEDIATELY HAD OBTAINED 6 BARS BUT THEN IT HAD DROPPED TO 4. THE PATIENT WAS REPORTED TO BE DOING WELL. SHE HAD A BATTERY REVISION, DURING WHICH TIME THE BATTERY WAS MOVED FROM THE ABDOMEN TO THE UPPER BUTTOCK. THE PATIENT NOW WAS ABLE TO RECHARGE WITH MAXIMAL EFFICIENCY AND THE DEVICE WAS FUNCTIONING WELL, CONSISTENT WITH PATIENT EXPECTATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 Required Intervention