BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 5738209 · Received June 21, 2016

    Report

    Report Number
    3004209178-2016-12587
    Event Type
    Injury
    Date Received
    June 21, 2016
    Date of Event
    April 4, 2016
    Report Date
    June 21, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THEY HAD PAIN AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE SINCE (B)(6) 2016. THE PAIN STARTED SUDDENLY AND WAS WAKING THEM UP IN THE MIDDLE NIGHT. THE PATIENT STATED THAT THEY WENT TO THEIR HEALTHCARE PROFESSIONAL (HCP) ON (B)(6) 2016 AND THE INS FELT LIKE IT WAS TRYING TO PUSH UP AND THROUGH THE SKIN. IT WAS HARD TO LAY, STAND, OR SIT. THE HCP DID AN X-RAY THAT SHOWED THE LEADS WERE STILL IN PLACE AND "EVERYTHING LOOKED GREAT". THE HCP ALSO TOLD THEM THAT THE INS HAD A LIFE SPAN OF 5 YEARS AND THAT IT NEEDED TO BE REPLACED. FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT WAS SCHEDULED FOR A REVISION. THE CAUSE OF THE PAIN AT THE INS SITE WAS NOT DETERMINED AND THE PAIN ISSUE WAS NOT RESOLVED AT THE TIME OF REPORT. THE INDICATION FOR USE FOR THE IMPLANTED DEVICE WAS NOTED AS FAILED BACK SURGERY SYNDROME. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392943 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention