BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3050907 · Received April 10, 2013

    Report

    Report Number
    1644487-2013-00820
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    November 1, 2013
    Report Date
    March 11, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THIS PATIENT'S DEVICE WAS REPLACED DUE TO CLINICAL EOS. THE PATIENT'S CHART INDICATED THE BATTERY EXPIRED AND THAT THIS WAS DETERMINED TO BE DUE TO AN INCREASE IN DEPRESSION OVER THE FEW WEEKS PRIOR TO SURGERY; HOWEVER, THE RELATION TO BASELINE WAS UNKNOWN. THE PATIENT HAD NOT BEEN SCHEDULED FOR FOLLOW-UP TO DETERMINE IF THE EVENTS HAD RESOLVED. ON (B)(6) 2013, THIS VNS PATIENT UNDERWENT GENERATOR REVISION, REPORTEDLY DUE TO END OF LIFE. THE GENERATOR WAS RETURNED, UNDERWENT PRODUCT ANALYSIS, AND WAS FOUND TO BE NOT AT END OF LIFE. THE REPORTED "EOS/ERI" ALLEGATION WAS NOT DUPLICATED IN THE PA LABORATORY. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WAS NO CONDITION NOTED DURING THE PRODUCT ANALYSIS EVALUATION THAT WOULD SUGGEST ANY ANOMALY WITH THE DEVICE. A BLC SHOWED 6.66 YEARS REMAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148617 PULSE GEN MODEL 102 GENERATOR MUZ CYBERONICS INC 102 015484

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR