BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 4382184 · Received January 5, 2015

    Report

    Report Number
    1644487-2015-03520
    Event Type
    Malfunction
    Date Received
    January 5, 2015
    Date of Event
    January 1, 2014
    Report Date
    December 8, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY. BRAND NAME, CORRECTED DATA: PULSE GEN MODEL 103. INITIAL MDR INADVERTENTLY LISTED THE WRONG PRODUCT BRAND NAME. TYPE OF DEVICE, NAME, CORRECTED DATA: GENERATOR. INITIAL MDR INADVERTENTLY LISTED THE WRONG PRODUCT INFORMATION. TYPE OF DEVICE, CODE, CORRECTED DATA: LYJ. INITIAL MDR INADVERTENTLY LISTED THE WRONG PRODUCT INFORMATION. MODEL#, CORRECTED DATA: 103. INITIAL MDR INADVERTENTLY LISTED THE WRONG PRODUCT MODEL #. SERIAL#, CORRECTED DATA: (B)(3). INITIAL MDR INADVERTENTLY LISTED THE WRONG PRODUCT SERIAL #. LOT#, CORRECTED DATA: 202115. INITIAL MDR INADVERTENTLY LISTED THE WRONG PRODUCT LOT #. EXPIRATION DATE #, CORRECTED DATA: 03/31/2014. INITIAL MDR INADVERTENTLY LISTED THE WRONG EXPIRATION DATE #. IF IMPLANTED, GIVE DATE, CORRECTED DATA: 04/30/2012. INITIAL MDR INADVERTENTLY LISTED THE WRONG IMPLANT DATE.

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ADDITIONAL PROGRAMMING HISTORY DATA WAS RECEIVED CONFIRMING THE HIGH IMPEDANCE. REVIEW OF THE DECODER DATA INDICATES THAT HIGH IMPEDANCE WAS PRESENT PRIOR TO (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE DIAGNOSTICS RESULTED IN HIGH IMPEDANCE (>= 10,000 OHMS) AND IFI - YES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RECENT INCREASE IN SEIZURES BELIEVED TO BE CAUSED BY THE HIGH IMPEDANCE. THE INCREASE WAS NOT ABOVE THE PATIENT'S PRE-VNS BASELINE FREQUENCY. THERE WAS NO TRAUMA THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTE TO THE HIGH IMPEDANCE. THE PATIENT WAS REFERRED FOR SURGERY. NO X-RAYS WERE PERFORMED. IT WAS REPORTED THAT THE DEVICE WAS NOT PROGRAMMED OFF AFTER OBSERVING THE HIGH IMPEDANCE, BUT THAT THE PATIENT WOULD BE BROUGHT BACK IN TO PROGRAM THE DEVICE OFF THE FOLLOWING DAY. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2014. AN IMPLANT CARD WAS RECEIVED INDICATING THAT ONLY THE GENERATOR WAS REPLACED AND THAT LEAD IMPEDANCE WITH THE NEW GENERATOR ATTACHED TO THE EXISTING LEAD WAS WITHIN NORMAL LIMITS. IT WAS REPORTED THAT THE HIGH IMPEDANCE RESOLVED WITH GENERATOR REPLACEMENT. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. THE EXPLANTED GENERATOR WAS DISCARDED; THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4458 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202115

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR