BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3053508 · Received April 11, 2013

    Report

    Report Number
    3004209178-2013-06035
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS TRIGEMINAL NEURALGIA. CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A DEVICE IMPLANTED THE WEEK PRIOR TO THE REPORT. THE REPORTER STATED THAT THE PATIENT STARTED SHAKING AND SWEATING 'REAL BAD' THE DAY OF THE REPORT. IT WAS NOTED THAT THE PATIENT WAS STILL HAVING SYMPTOMS AT THE TIME OF THE REPORT. THE REPORTER STATED THAT BEFORE THE PATIENT HAD A DEVICE HE HAD SEIZURES. IT WAS REPORTED THAT THE PATIENT HAD THE DEVICE FOR TRIGEMINAL NEURALGIA AND THE LEADS WERE IMPLANTED IN THE PATIENT'S BRAIN. SIX MONTHS LATER, ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM ON (B)(6) 2012. THE REPORTER STATED THAT THE PATIENT WAS HAVING PAIN IN THE LEFT SHOULDER CHEST AREA WHERE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS LOCATED. AN X-RAY WAS TAKEN AND NO FRACTURES WERE FOUND. IT WAS REPORTED THAT THE EMERGENCY ROOM DOCTOR THOUGHT THE CONNECTOR LOOKED FUNNY AND THE NURSE THOUGHT THERE WAS NOTHING WRONG WITH IT. IT WAS NOTED THAT THE PATIENT HAD A CONNECTOR BECAUSE HE HAD AN OLD SYSTEM. IT WAS REPORTED THAT THE PATIENT STAYED OVERNIGHT IN THE HOSPITAL AND THEY DID TELEMETRY. THE REPORTER STATED THAT THE PATIENT HAD AN ELECTROCARDIOGRAM AND IT WAS NORMAL AND THE PATIENT'S 'THROMBOLYSIS IN MYOCARDIAL INFARCTION' SCORE WAS ZERO. IT WAS REPORTED THAT THE PATIENT WAS GIVEN A NITRO PATCH WHICH SEEMED TO RESOLVE THE PAIN. THE REPORTER STATED THAT THE PATIENT SAW HIS DOCTOR ON (B)(6) 2012 AND THE PATIENT WAS NOT REPROGRAMMED. IT WAS NOTED THAT THE INCISIONS WERE HEALED AND THE PATIENT DID NOT INDICATE AN ISSUE IN REGARD TO SWEATING AND SHAKING. IT WAS REPORTED THAT THE PATIENT SEEMED TO BE DOING WELL PAIN-WISE AND THE PATIENT WAS GOING TO HAVE A STIMULATION TRIAL FOR PAIN IN THE LOWER EXTREMITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156174 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 Hospitalization