BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3922630 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12721
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 13, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37713, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 3550-39, LOT# N251848, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION; PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER; PRODUCT ID 37713, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION IN (B)(6) 2011. THE PATIENT SAW AN ERROR CODE ON THEIR RECHARGER WHEN THE WIRE IN THEIR BODY BROKE. THE TITANIUM HOUSING BROKE. THE PATIENT HAD A SURGICAL REVISION AND MORE SLACK WAS ALLOWED ON THE LEAD WIRE. THE LEAD WIRE WAS REPLACED. IT WAS NOTED THAT THE PATIENT'S STIMULATOR'S WERE WORKING GREAT AND THEY COULDN'T IMAGINE NOT HAVING THEM. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COMPONENT INVOLVED IN THE EVENT WAS THE EXTENSION. TROUBLESHOOTING CONSISTED OF AN X-RAY AND REPROGRAMMING. ACTIONS TAKEN TO RESOLVE THE ISSUE WERE NOTED AS REPLACEMENT OF EXTENSION AND REPROGRAMMING. IT WAS ALSO NOTED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED AND IT WAS UNKNOWN IF IT WAS RELATED TO THE DEVICE. THE PATIENT REPORTEDLY RECOVERED WITHOUT PERMANENT IMPAIRMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. THE PATIENT HAS TWO IMPLANTABLE NEUROSTIMULATORS AND IT IS UNCLEAR WHICH STIMULATOR IS EXPERIENCING THE ISSUES. PLEASE REFER TO MANUFACTURER REPORT # 3004209178-2014-12488 FOR INFORMATION ON THE OTHER STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401043 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