BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2212107 · Received August 15, 2011

    Report

    Report Number
    1644487-2011-01872
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY MANUFACTURER, COULD NOT BE ASCERTAINED WHETHER OR NOT THE LEAD PIN WAS FULLY INSERTED PAST THE CONNECTOR BLOCK OF THE GENERATOR. BRAND NAME; COMMON DEVICE NAME; MODEL #, LOT #, EXPIRATION DATE, SERIAL NUMBER; DEVICE MANUFACTURE DATE; CORRECTED DATA: INITIAL REPORT INADVERTENTLY LISTED WRONG PRODUCT.

    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 INFORMATION WAS RECEIVED ON (B)(4) 2011, WHEN THE PHYSICIAN REPORTED HE WAS NOT AWARE OF ANY TRAUMA TO THE DEVICE. AP AND LATERAL X-RAYS OF THE PATIENT'S NECK AND CHEST WERE RECEIVED BY THE MANUFACTURER AND REVIEWED ON (B)(4) 2011. BASED ON THE X-RAY ANGLE, IT COULD NOT BE CONFIRMED WHETHER OR NOT THE LEAD CONNECTOR PIN WAS FULLY INSERTED INTO THE HEADER OF THE GENERATOR. AS IT CANNOT BE VISUALIZED PAST THE CONNECTOR BLOCK. THERE DID NOT APPEAR TO BE ANY GROSS FRACTURES BUT THERE WAS A PORTION OF THE LEAD BODY BEHIND THE GENERATOR THAT WAS UNABLE TO BE ASSESSED. THE PATIENT WAS SCHEDULED FOR SURGERY ON (B)(6) 2011. THE MANUFACTURER'S CONSULTANT REPORTED THAT HE RAN A SYSTEMS DIAGNOSTICS PRIOR TO SURGERY WHICH SHOWED LEAD IMPEDANCE = HIGH/IMPEDANCE VALUE GREATER THAN 10,000 OHMS. DURING SURGERY THE SURGEON OPENED UP THE GENERATOR POCKET AND PULLED OUT THE GENERATOR. THE SURGEON EXAMINED THE LEAD CONNECTOR PIN AND IT APPEARED TO BE FULLY INSERTED INTO THE HEADER OF THE GENERATOR. THE SURGEON REMOVED THE LEAD CONNECTOR PIN FROM THE GENERATOR, CLEANED OFF THE LEAD AND THE GENERATOR, AND THEN REINSERTED THE LEAD CONNECTOR PIN INTO THE GENERATOR HEADER. THE SURGEON THEN RAN SYSTEM DIAGNOSTICS WHICH REVEALED THE HIGH IMPEDANCE HAD BEEN RESOLVED; OUTPUT = OK/LEAD IMPEDANCE = OK/IMPEDANCE VALUE = 3214 OHMS. THEY RAN SYSTEM DIAGNOSTICS TWICE OUTSIDE THE GENERATOR POCKET AND THEN INSERTED THE GENERATOR INSIDE THE POCKET AND RAN SYSTEMS DIAGNOSTICS AGAIN. ALL THE DIAGNOSTICS SHOWED RESULTS WITHIN NORMAL LIMITS. THE PATIENT WAS LEFT DISABLED BUT THE PATIENT WILL BE PROGRAMMED BACK ON IN A WEEK OR SO WHEN THE PHYSICIAN GETS BACK FROM VACATION. THE PATIENT'S PARENTS REPORTED THAT THE PATIENT HAS GREAT EFFICACY WITH VNS AND THAT HER SEIZURE CLUSTERS HAVE COMPLETELY STOPPED WITH AN OUTPUT OF 2.5 MA. THEY ALSO REPORTED THAT HER MOOD HAD IMPROVED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A VNS TREATING PHYSICIAN REPORTED THAT WHEN HE INTERROGATED THE VNS PATIENT THAT DAY, A HIGH LEAD IMPEDANCE MESSAGE DISPLAYED. HE THEN RE-INTERROGATED THE PATIENT AND THE MESSAGE DID NOT REAPPEAR. THE PHYSICIAN INCREASED THE PATIENT'S OUTPUT CURRENT FROM 1MA TO 1.25MA AND RE-INTERROGATED THE PATIENT AGAIN BUT THE HIGH IMPEDANCE MESSAGE DID NOT DISPLAY AGAIN. THE PATIENT DID NOT SEEM TO HAVE ANY DISCOMFORT. THE PATIENT WAS SEEN AGAIN ON (B)(6) 2011 BY THE PHYSICIAN AND A SYSTEM DIAGNOSTICS TEST REVEALED OUTPUT=LOW/CURRENT DELIVERED=0MA/LEAD IMPEDANCE=HIGH/IMPEDANCE VALUE GREATER THAN 10,000OHMS. THE CONSULTANT RECOMMENDED THAT THE PHYSICIAN DISABLE THE GENERATOR. THE PATIENT WAS SENT FOR X-RAYS AND THE PHYSICIAN REPORTED THAT THEY LOOK GOOD WITH NO BREAK IN THE LEAD. THE PHYSICIAN SAID HE WOULD SEND THE X-RAYS TO THE MANUFACTURER FOR REVIEW BUT THEY HAVE NOT YET BEEN RECEIVED. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 2826

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR