BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3058668 · Received April 15, 2013

    Report

    Report Number
    3004209178-2013-06276
    Event Type
    Malfunction
    Date Received
    April 15, 2013
    Report Date
    April 2, 2013
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3888-45 LOT# V179754, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3550-39 LOT# N230410, IMPLANTED: 2009 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID: 3708220 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3888-45 LOT# V179184, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3550-39 LOT# N231447, IMPLANTED: 2009 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID: 3778-60 LOT# SERIAL #(B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A FALL, AND NOW WAS HAVING DIFFICULTY RECHARGING. IT WAS STATED THAT THERE WAS STIMULATION IN THE WRONG LOCATION, AS THE DEVICE WAS STIMULATING THE LEFT LEG INSTEAD OF THE RIGHT LEG. THE MANUFACTURER REPRESENTATIVE WAS REPORTEDLY GOING TO CHECK RECHARGING ISSUES AND IMPEDANCES. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS ABLE TO RECHARGE HER BATTERY "FINE". IT WAS STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT FLIPPED AND THE PATIENT GOT 8 OUT OF 8 COUPLING BARS. IT WAS STATED THAT THE LEAD "MAY" HAVE MOVED. THE PATIENT WAS RECOVERING FROM FOOT SURGERY AND THE DOCTOR WANTED TO WAIT UNTIL SHE WAS HEALED BEFORE CONSIDERING A REVISION. IT WAS STATED THAT THEDOCTOR DID NOT THINK IT WAS NECESSARY TO DO AN X-RAY TO VERIFY THE LEAD PLACEMENT AT THIS TIME. THE PATIENT WAS SUPPOSED TO FOLLOW UP WITH THE DOCTOR AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160288 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