BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2823345 · Received November 7, 2012

    Report

    Report Number
    1644487-2012-02920
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 9, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR WAS RECEIVED BY THE MANUFACTURER ON (B)(6) 2012. HOWEVER, PRODUCT ANALYSIS HAS NOT BEEN COMPLETED TO DATE. THE RETURN PRODUCT FORM CONFIRMED THE GENREATOR REPLACEMENT DATE ON (B)(6) 2012, AND THE REASON FOR REPLACEMENT WAS MARKED AS "END OF SERVICE (BATTERY DEPLETION)."

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S CAREGIVER THAT THE PATIENT HAD GENERATOR REPLACEMENT SURGERY ON (B)(6) 2012. THE TREATING PHYSICIAN REPORTED TO THE CAREGIVER THAT THE DEVICE COULD NOT BE INTERROGATED AND NEEDED TO BE REPLACED. NO PATIENT ADVERSE EVENTS HAVE BEEN REPORTED. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. ATTEMPTS FOR PRODUCT RETURN ARE UNDERWAY, BUT THE PRODUCT HAS NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE.

    Description of Event or Problem · 1

    THE IMPLANT CARD WAS RECEIVED BY THE MANUFACTURER AND CONFIRMED THE DATE OF GENERATOR REPLACEMENT ON (B)(6) 2012. THE REASON WAS INDICATED AS BATTERY DEPLETION WITH NEAR END OF SEVICE=YES.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS OF THE EXPLANTED GENERATOR WAS COMPLETED. THE ALLEGED END OF SERVICE AND FAILURE TO INTERROGATE THE GENERATOR WAS DETERMINED TO BE THE RESULT OF NORMAL BATTERY DEPLETION. THE DEPLETION WAS AN EXPECTED EVENT AS DETERMINED BY BATTERY LIFE CALCULATION AND BATTERY VOLTAGE MEASUREMENT. THE MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WAS NO CONDITION NOTED DURING THE PRODUCT ANALYSIS EVALUATION THAT WOULD SUGGEST ANY ANOMALY WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 015484

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR