BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3843892 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09983
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3986A LOT# N329504, IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3986A LOT# N229140, IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6);: PRODUCT TYPE EXTENSION PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 97740, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT MET WITH THE HEALTH CARE PROFESSIONAL ONCE AND WAS ADVISED TO KEEP THE STIMULATION OFF FOR NOW. THE PATIENT HAD AN APPOINTMENT THREE DAYS LATER TO DISCUSS ON POINT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD AN APPOINTMENT SCHEDULED WITH THE HEALTH CARE PROFESSIONAL FOR (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT POINT LEAD WAS DISCUSSED WITH THE PATIENT AND AT THAT TIME, THE SYSTEM STILL REMAINED OFF. IT WAS NOTED THAT THERE WERE NO CHANGES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS NOT DETERMINED IF THE SEIZURE WAS DUE TO STIMULATION. IT WAS NOTED THAT THE PATIENT STARTED TO USE HIS STIMULATION AGAIN AND AS OF THE DAY OF THE REPORT, THERE WERE NO ISSUES. IT WAS NOTED THAT THE PATIENT WAS MOVING FORWARD WITH AN ON-POINT LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN A REPROGRAMMING SESSION ON THE AFTERNOON OF THE REPORT AND WHILE ADJUSTING THE STIMULATOR, THE PATIENT APPEARED TO HAVE A SEIZURE. IT WAS NOTED THAT THE PATIENT WAS STILL IN THE EMERGENCY ROOM AND WOULD HAVE A HEAD COMPUTERIZED TOMOGRAPHY (CT) SCAN. IT WAS NOTED THAT THE EVENT OCCURRED AT THE HOSPITAL AND THAT THE PATIENT WAS ABLE TO RECOGNIZE THE REPORTER AND WAS COHERENT. IT WAS NOTED THAT THE PATIENT HAD TWO SURGICAL LEADS FROM (B)(6) 2013 THAT ARE USED FOR MOTOR CORTEX STIMULATION AND WERE BENEATH THE SKULL ON TOP OF THE DURA. IT WAS FURTHER REPORTED THAT NO MALFUNCTIONS WERE SEEN AND THE CAUSE WAS UNKNOWN. IT WAS NOTED THAT THE PATIENT WAS IN THE PROCESS OF GETTING A FOLLOW-UP SCHEDULED WITH THE HEALTH CARE PROFESSIONAL. THE REPORTER NOTED THAT THE PATIENT WAS DOING FINE AT THE TIME OF THE REPORT. THE PATIENT HAD THE STIMULATOR TURNED OFF AND WOULD NOT BE USING IT AGAIN UNTIL HIS FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321149 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Other| R