BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3951041 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13378
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    June 30, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR SYSTEM REMOVED AROUND (B)(6) 2014 IN ORDER TO HAVE AN MRI. THE PATIENT WAS EXPERIENCING OTHER BACK ISSUES AND THAT WAS THE REASON FOR THE MRI. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. ABOUT 3 MONTHS PRIOR TO THE REPORT THE PATIENT¿S STIMULATION WASN¿T HELPING WITH THE PAIN ANYMORE. THE PATIENT DID WORK WITH THEIR DOCTOR FOR REPROGRAMMING. THE PATIENT WASN¿T SURE IF ALL OF THEIR WIRES WERE REMOVED. THEIR DOCTOR MENTIONED HAVING TO CUT AND CLIP THE WIRE BUT THE PATIENT WAS GOING TO VERIFY THAT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428248 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