BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 3863988 · Received June 10, 2014

    Report

    Report Number
    1644487-2014-01451
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 2, 2026
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LATER, THE PATIENT UNDERWENT A GENERATOR REPLACEMENT SURGERY. THIS WAS NOTED TO BE A PROPHYLACTIC REPLACEMENT. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE.

    Description of Event or Problem · 0

    LATER, THE PATIENT UNDERWENT A REVISION SURGERY. IT WAS DETERMINED THAT THIS REVISION WAS DUE TO PAIN AT THE GENERATOR SITE. THE PATIENT'S GENERATOR PLACEMENT WAS REVISED AS A RESULT. THE GENERATOR WAS MOVED FROM BEING CLOSER TO THE ARMPIT, TO MORE MEDIAL AND CLOSER TO THE CHEST. THE SURGEON TUNNELED THE LEAD AND RECONNECTED THE EXISTING GENERATOR. NO PRODUCTS WERE EXCHANGED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF X-RAYS BY THE MANUFACTURER REVEALED INCOMPLETE LEAD PIN INSERTION. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE GENERATOR PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT¿S DEVICE SHOWED HIGH IMPEDANCE. THE PATIENT WAS RE-POSITIONED AND THE DEVICE WAS RETESTED, BUT THE DEVICE CONTINUED TO SHOW HIGH IMPEDANCE. PATIENT MANIPULATION OR TRAUMA IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. THE DEVICE WAS ONLY DISABLED TO TAKE X-RAYS. X-RAYS DATED (B)(6) 2014 WERE PROVIDED TO THE MANUFACTURER FOR FURTHER REVIEW. THE GENERATOR APPEARS IN THE LEFT CHEST IN A NORMAL PLACEMENT. THE FILTER FEED-THROUGH WIRES APPEAR TO BE INTACT. THE LEAD CONNECTOR PIN DOES NOT APPEAR TO BE FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. THE ELECTRODES APPEARED TO BE PLACED IN NORMAL ARRANGEMENT. PART OF THE LEAD WAS BEHIND THE GENERATOR AND COULD NOT BE ASSESSED. NO CLEAR LEAD BREAKS OR SHARP ANGLES WERE FOUND IN THE PARTS OF THE LEAD THAT COULD BE ASSESSED. BASED ON THE IMAGES PROVIDED, THE CAUSE OF THE HIGH LEAD IMPEDANCE IS LIKELY DUE TO INCOMPLETE LEAD PIN INSERTION. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT COMPLAINED OF SEVERE PAIN IN HIS LEFT NECK AREA DURING AN OFFICE VISIT ON (B)(6) 2014. THE PATIENT¿S DEVICE WAS TESTED DURING THE OFFICE VISIT AND DIAGNOSTIC RESULTS SHOWED HIGH IMPEDANCE. THE PATIENT WAS SENT FOR X-RAYS AND THE RADIOLOGIST NOTED A LEAD BREAK IN THE LEAD PORTION NEAR THE GENERATOR; HOWEVER, THE NEUROLOGIST STATED THAT HE WAS UNABLE TO OBSERVE ANY LEAD DISCONTINUITIES IN THE X-RAY IMAGES. THE PATIENT¿S DEVICE WAS DISABLED AND THE PATIENT WAS REFERRED FOR SURGERY. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356204 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 202722

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Required Intervention