BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3961783 · Received July 28, 2014

    Report

    Report Number
    3004209178-2014-13607
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 7, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 39565-30, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT FELL AND HAD POOR COVERAGE. AN X-RAY WAS DONE TO PROVIDE INSIGHT TO THE ISSUE. COMPONENTS INVOLVED IN THE EVENT INCLUDED THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD. ACTIONS TAKEN TO RESOLVE ISSUE INCLUDED REPROGRAMMING. THE CAUSE OF EVENT WAS DETERMINED AND WAS NOT CONSIDERED TO BE DEVICE RELATED. THERE WAS A 50% OR GREATER SYMPTOM REDUCTION. THE PATIENT OUTCOME WAS RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL ON SATURDAY AND NOW THE CALLER WAS NOT ABLE TO CHARGE THE IMPLANT. THE CALLER WAS FRIEND AND/OR FAMILY OF THE PATIENT. IT WAS NOTED THAT THERE WAS A COMMUNICATION PROBLEM. IT WAS NOTED THAT THE PATIENT WAS NOT FEELING STIMULATION. IT WAS NOTED THAT THE RECHARGER ANTENNA WAS PLACED OVER THE IMPLANTABLE NEUROSTIMULATOR (INS), THE START CHARGE BUTTON WAS PRESSED, AND THE REPOSITION ANTENNA SCREEN WAS OBSERVED. IT WAS NOTED THAT CHARGING WAS ATTEMPTED ONE DAY PRIOR TO REPORT AND THEY WERE NOT ABLE TO CHARGE. IT WAS ALSO NOTED THAT THE LAST TIME THE PATIENT WAS ABLE TO CHARGE WAS ¿ABOUT¿ THREE WEEKS PRIOR TO REPORT. THE CALLER WAS REDIRECTED TO THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP). ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439831 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 00059 YR