BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 002-1100 15W THERMAL THERAPY

    MDR report key: 5475547 · Received March 2, 2016

    Report

    Report Number
    1723170-2016-00223
    Event Type
    Injury
    Date Received
    March 2, 2016
    Date of Event
    December 30, 2015
    Report Date
    March 2, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS NOT PROVIDED BY THE AUTHORS. CITATION: DREDLA BK, LUCAS JA, WHAREN RE, TATUM WO. NEUROCOGNITIVE OUTCOME FOLLOWING STEREOTACTIC LASER ABLATION IN TWO PATIENTS WITH MRI/PET PLUS MTLE. EPILEPSY & BEHAVIOR 2016;(56):44¿47. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S VISUALASE SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO MALFUNCTION IS ALLEGED, THEREFORE NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    BRYNN K. DREDLA, JOHN A. LUCAS, ROBER E.WHAREN,AND WILLIAM O. TATUM CONCLUDED THE FOLLOWING: WE CONCLUDE THAT MRGLITT MAY PRODUCE MEMORY DECLINE IN ADULT PATIENTS WITH DRUG-RESISTANT MRI-/PET+ MTLE BUT MAY OTHERWISE SPARE OTHER ASPECTS OF NEUROCOGNITIVE FUNCTION. THIS REPRESENTS A SIGNIFICANT MINORITY OF PATIENTS THAT MAY REFLECT A PATHOLOGY-SPECIFIC RISK FOR PATIENTS UNDERGOING MRGLITT. SPECIFICALLY, IN PATIENT 2. FOUR MONTHS POSTPROCEDURE, NEUROPSYCHOLOGICAL TESTING DEMONSTRATED DECLINES IN VERBAL AND VISUAL MEMORY BY A MAGNITUDE OF 2 SD COMPARED TO PRESURGICAL BASELINE, AND SEMANTIC VERBAL FLUENCY SCORES DECLINED BY 1.2 SD. OTHER COGNITIVE DOMAINS REMAINED ESSENTIALLY STABLE OVER TIME. HE HAD THREE SEIZURES IN THE FIRST MONTHS WHICH WERE ATTRIBUTED TO LOW ASD LEVELS. HE HAS SINCE REMAINED SEIZURE-FREE. HE CONTINUES TO ENDORSE MEMORY DIFFICULTY ON A DAY-TO-DAY BASIS DESPITE NEUROCOGNITIVE REHABILITATION FOLLOWING POSTOPERATIVE NEUROPSYCHOLOGICAL TESTING. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S VISUALASE SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131638 SYSTEM 002-1100 15W THERMAL THERAPY POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC. (LOUISVILLE)

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Disability