BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2920390 · Received January 17, 2013

    Report

    Report Number
    1644487-2013-00179
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    November 9, 2012
    Report Date
    December 21, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED ON (B)(6) 2013 CONFIRMING THAT THE PATIENT UNDERWENT PROPHYLACTIC GENERATOR REVISION (B)(6) 2012.

    Description of Event or Problem · 1

    ON (B)(6) 2012 IT WAS REPORTED THAT THE VNS PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT SURGERY DUE TO A BATTERY LIFE CALCULATION OF ABOUT 4 MONTHS REMAINING UNTIL ERI=YES AND AN INCREASE IN SEIZURE ACTIVITY. THE PATIENT UNDERWENT GENERATOR REPLACEMENT ON (B)(6) 2012. THE PHYSICIAN LATER REPORTED THAT THE INCREASE IN SEIZURES WAS FIRST OBSERVED ON (B)(6) 2012 AND THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2012. IT WAS NOTED THAT THE LAST SYSTEM AND NORMAL MODE DIAGNOSTICS SHOWED RESULTS WITHIN NORMAL LIMITS OF DCDC=1/ERI=NO AND DCDC=4/ERI=NO RESPECTIVELY. THE PHYSICIAN THEN STATED THAT THE BATTERY LIFE CALCULATION PERFORMED ON (B)(6) 2012 RESULTED IN 0 YEARS REMAINING UNTIL ERI=YES. THE ONLY INTERVENTION FOR THE INCREASE IN SEIZURES WAS TO REPLACE THE PATIENT'S GENERATOR. NO CAUSAL OR CONTRIBUTORY PROGRAMMING CHANGES, MEDICATION CHANGES, OR OTHER EXTERNAL FACTORS PRECEDE THE ONSET OF THE INCREASE IN SEIZURES. THE PHYSICIAN STATED HE HAS NOT SEEN THE PATIENT SINCE THE BATTERY REPLACEMENT SURGERY SO HE DID NOT KNOW IF THE PATIENT'S SEIZURE FREQUENCY HAS SINCE IMPROVED. ATTEMPTS WERE MADE FOR THE RETURN OF THE EXPLANTED GENERATOR WERE MADE BUT THE FACILITY APPEARS TO HAVE DISCARDED IT AS THEY DID NOT HAVE IT ANY LONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25333 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 2497

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention