BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 3052422 · Received April 11, 2013

    Report

    Report Number
    1644487-2013-00981
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    July 23, 2001
    Report Date
    March 12, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S VNS GENERATOR BATTERY WAS DEPLETED AND FAILED TO COMMUNICATE WITH THE VNS PROGRAMMING COMPUTER DUE TO BATTERY DEPLETION. THE EOS CONDITION WAS AN EXPECTED EVENT BASED ON THE BATTERY ESTIMATE (-2.56 YEARS). THE VNS GENERATOR WAS REPLACED ON (B)(6) 2012 AND WAS RETURNED TO THE MANUFACTURER ON (B)(6) 2013 FOR PRODUCT ANALYSIS. PRODUCT ANALYSIS ON THE VNS GENERATOR REVEALED THAT THE GENERATOR'S BATTERY WAS DEPLETED BUT THE SUPPLY CURRENT PULSING WAS OUT-OF-SPECIFICATION. ANALYSIS INDICATED THAT DURING MANUFACTURE OF THE GENERATOR, THE R35 RESISTOR (A SELECTABLE VALUE RESISTOR) COULD HAVE BEEN MORE OPTIMALLY CHOSEN. A LOWER VALUE RESISTOR WOULD HAVE MORE SUITABLY CENTERED THE CURRENTS WITHIN THEIR LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156504 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS INC 101 3673

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR