BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2559124 · Received May 3, 2012

    Report

    Report Number
    3004209178-2012-02971
    Event Type
    Injury
    Date Received
    May 3, 2012
    Report Date
    April 9, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748925 LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2003 EXPLANTED:; PRODUCT TYPE EXTENSION PRODUCT ID 748925 LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2003 EXPLANTED:; PRODUCT TYPE EXTENSION PRODUCT ID 74002 LOT# N233257 SERIAL# IMPLANTED: (B)(6) 2010 EXPLANTED:; PRODUCT TYPE ADAPTER PRODUCT ID 37752 LOT# SERIAL# (B)(4) IMPLANTED: EXPLANTED:; PRODUCT TYPE RECHARGER PRODUCT ID 37743 LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2010 EXPLANTED:; PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3487A-33 LOT# J0118292V SERIAL# IMPLANTED: (B)(6) 2002 EXPLANTED:; PRODUCT TYPE LEAD PRODUCT ID 3487A-33 LOT# J0120565V SERIAL# IMPLANTED: (B)(6) 2002 EXPLANTED:; PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT APPROXIMATELY TWO WEEKS BEFORE TROUBLESHOOTING. THE PATIENT HAD VERY LITTLE STIMULATION WHEN SITTING OR STANDING, AND NO STIMULATION WHEN LYING DOWN. TROUBLESHOOTING REVEALED ABNORMAL HIGH IMPEDANCE READINGS (2900, 4000, 5000 RANGE) ON THE RIGHT LEAD. THE MEASUREMENT WAS TOO HIGH FOR THE PATIENT TO FEEL STIMULATION ON THE RIGHT SIDE. STIMULATION WAS OK ON THE LEFT SIDE. REPROGRAMMING WAS UNABLE TO GET COVERAGE ON THE PATIENT'S RIGHT SIDE. THE PATIENT WAS GOING TO SEE THE PHYSICIAN FOR LEAD REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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