BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GENERATOR 102

    MDR report key: 2981342 · Received February 27, 2013

    Report

    Report Number
    1644487-2013-00513
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 30, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY. SUPPLEMENTAL MANUFACTURER REPORT #02 INADVERTENTLY DID NOT INCLUDE PROGRAMMING AND DIAGNOSTIC HISTORY AND INCORRECTLY REPORTED THE BATTERY LIFE CALCULATION RESULTS.

    Additional Manufacturer Narrative · 1

    (B)(4). SUPPLEMENTAL MFR REPORT #2 LISTED THE WRONG DATE IN THIS FIELD. THE DATE SHOULD HAVE BEEN (B)(4) 2013 RATHER THAN (B)(4) 2013. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS OF THE LEAD CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    NEW INFORMATION WAS PROVIDED BY THE PHYSICIAN WHERE THE PATIENT'S SETTINGS FROM THE DAY OF IMPLANT (B)(6) 2011 TO (B)(6) 2012 WAS GIVEN. AN APPROXIMATE BLC (BATTERY LIFE CALCULATION) WAS PERFORMED USING THE SETTINGS THE PHYSICIAN PROVIDED. A DCDC OF 2 WAS USED FOR ALL PARAMETERS. THE BLC RESULTED IN 1.28 YEARS TILL EOS. THE PATIENT HAS BEEN REFERRED FOR A GENERATOR REPLACEMENT, BUT SURGERY HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    THE PROGRAMMING HISTORY DATABASE WAS REVIEWED FOR PATIENT'S UPDATED PROGRAMMING SETTINGS. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH RESULTED IN 1.73 YEARS TILL EOS.

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED THAT INDICATED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT ON (B)(6) 2013 DUE TO BATTERY DEPLETION, NEAR EOS = YES. ATTEMPTS TO HAVE THE GENERATOR RETURNED FOR ANALYSIS HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY SHOWED THAT DIAGNOSTIC RESULTS REVEALED AN ERI CONDITION ON (B)(6) 2012. A BATTERY LIFE CALCULATION USING THE AVAILABLE PROGRAMMING HISTORY SHOWED APPROXIMATELY 6.06 YEARS UNTIL NEAR END OF SERVICE WHEN THE FAILURE TO COMMUNICATE OCCURRED IN (B)(6) 2012. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE EXPLANTING FACILITY DISCARDED THE EXPLANTED DEVICE; THEREFORE, NO ANALYSIS CAN BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE VNS GENERATOR WAS NO LONGER FUNCTIONING AND THAT THE BATTERY WAS COMPLETELY DEAD. IT WAS LATER REVEALED THAT DURING THE PATIENT'S LAST VISIT THE VNS GENERATOR COULD NOT COMMUNICATE WITH THE VNS PROGRAMMING SYSTEM BECAUSE THE GENERATOR'S BATTERY WAS COMPLETELY DEPLETED. DURING THE OFFICE VISIT ON (B)(6) 2012 THE PATIENT WERE AT SETTINGS OUTPUT CURRENT= 2.75 MA/ FREQUENCY= 30 HZ/ PULSE WIDTH= 250 SEC/ON TIME= 14 SEC/OFF TIME= 0.5 MIN / MAGNET OUTPUT CURRENT= 3 MA/ ON TIME= 30 SEC/ PULSE WIDTH= 250 SEC. IT WAS NOTED THAT THE DEVICE DID NOT LAST AS LONG AS IT SHOULD WITH THE CURRENT SETTINGS SINCE THE PATIENT WAS IMPLANTED WITH THE VNS GENERATOR ON (B)(6) 2011. ATTEMPTS TO RETRIEVE ADDITIONAL PROGRAMMING HISTORY ARE UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84329 PULSE GENERATOR 102 GENERATOR LYJ CYBERONICS, INC. 102 2790

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR