BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2592113 · Received May 30, 2012

    Report

    Report Number
    3004209178-2012-03814
    Event Type
    Malfunction
    Date Received
    May 30, 2012
    Date of Event
    May 3, 2012
    Report Date
    May 3, 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
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3998 LOT# V163064 SERIAL#, IMPLANTED: 2009 (B)(6), EXPLANTED: PRODUCT TYP LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYP RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYP PROGRAMMER, PATIENT PRODUCT ID, 3708360 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID, 3708360 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: PRODUCT TYP EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT KEPT HER STIMULATION HIGH AND "THAT IT ALWAYS FEELS LIKE I'M GETTING AN ELECTRICAL SHOCK" BUT THAT SETTING COVERED HER PAIN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND THE CAUSE OF THE OVERSTIMULATION ISSUE WAS UNKNOWN. PATIENT WAS SEEN BY THE HEALTHCARE PROFESSIONAL (HCP) ON (B)(6) 2012 BUT THE INCIDENT WAS NOT MENTIONED. PATIENT DID NOT HAVE ANY SURGICAL INTERVENTION AND WAS ORDERED FOR A CT SCAN BY THE PATIENT'S SURGEON. PATIENT DID NOT HAVE HOSPITALIZATION AND NO SERIOUS INJURY/ ILLNESS WAS REPORTED.

    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 49 YR