BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3931756 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-12954
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    June 23, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-75, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3778-75, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LEAD REVISION ON THE DAY OF THE REPORT. THE LEAD PULLED AND MIGRATED AND THE LEAD WAS REPLACED ON THE DAY OF THE REPORT. IT WAS REPORTED THAT AFTER THE REVISION THE PATIENT HAD A GREATER THAT 50% SYMPTOM REDUCTION AND THEY HAD COVERAGE IN ALL AREAS THEY NEEDED. AN X-RAY HAD BEEN TAKEN AND THAT SHOWED THAT THE PATIENT¿S LEFT OCCIPITAL LEAD HAD MOVED. IT WAS UNKNOWN WHEN THE LEAD MIGRATION OCCURRED. IT WAS NOTED THAT THE PATIENT HAD INTENSE MUSCLE SPASMS OF THEIR SHOULDERS WHICH CAUSED THE LEAD TO MOVE DOWN AND THEY LOST COVERAGE ON THE LEFT SIDE OF THEIR HEAD. THE PATIENT WAS DOING WELL AND GETTING GREAT COVERAGE AT THE TIME OF THE REPORT. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MIGRATION WAS CONFIRMED VIA X-RAY ON (B)(6) 2014. IT WAS NOTED THAT THE PATIENT HAD BAD SPASMS ANYWAY. IT WAS NOTED THAT THIS WAS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410521 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 Required Intervention