BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2991035 · Received March 6, 2013

    Report

    Report Number
    1644487-2013-00600
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    January 31, 2013
    Report Date
    November 13, 2019
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, LEAD PIN NOT FULLY INSERTED PAST THE CONNECTOR BLOCK OF THE GENERATOR. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    DATE OF EXPLANT; CORRECTED DATA: ADDITIONAL INFORMATION INDICATES THAT THE GENERATOR WAS NOT EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHYSICIAN'S OFFICE THAT HIGH IMPEDANCE WAS OBSERVED ON A DIAGNOSTIC TEST WHEN THE PATIENT WAS SEEN ON (B)(6) 2013. NO PATIENT MANIPULATION OR TRAUMA OCCURRED PRIOR TO THE HIGH IMPEDANCE, AND NO INCREASE IN SEIZURES WAS OBSERVED. THE PATIENT'S DEVICE WAS NOT DISABLED AFTER THE HIGH IMPEDANCE WAS SEEN, EVEN THOUGH IT WAS RECOMMENDED TO PROGRAM THE DEVICE OFF WHEN HIGH IMPEDANCE IS SEEN. THE PATIENT HAS BEEN REFERRED TO A SURGEON; HOWEVER, NO SURGERY HAS BEEN PLANNED OR SCHEDULED. A NECK X-RAY WAS TAKEN AND THE PHYSICIAN WAS UNABLE TO DISCERN ANYTHING WRONG WITH THE SYSTEM FROM THE IMAGE. ADDITIONAL CHEST AND NECK X-RAYS WERE TAKEN AND SENT TO THE MANUFACTURER FOR REVIEW. THE GENERATOR WAS SEEN IN THE LEFT CHEST AREA. THE FILTER FEED THRU WIRES APPEAR INTACT AS DO THE LEAD WIRES AT THE CONNECTOR PIN. THE LEAD PIN CANNOT BE VISUALIZED PAST THE SECOND CONNECTOR BLOCK, INDICATING THAT IT MAY NOT BE FULLY INSERTED INTO THE GENERATOR. ALTHOUGH NO CLEAR LEAD BREAKS WERE OBSERVED, A SUSPECT AREA WAS SEEN IN THE LEAD ABOUT ONE TO TWO INCHES PAST THE CONNECTOR PIN. DUE TO THE CONTRAST AND IMAGE QUALITY, IT CANNOT BE DETERMINED IF THERE IS A BREAK IN THIS AREA OR IF IT IS AN ARTIFACT FROM THE IMAGE. THE ELECTRODES APPEAR TO BE IN PROPER ALIGNMENT AND A STRAIN RELIEF BEND WAS OBSERVED. NO STRAIN RELIEF LOOP WAS OBSERVED. BASED ON THE IMAGES PROVIDED, THE CAUSE OF THE HIGH IMPEDANCE MAY POSSIBLY BE DUE TO THE LEAD PIN NOT BEING FULLY INSERTED INTO THE GENERATOR; HOWEVER, THIS CANNOT BE CONFIRMED BASED ON IMAGES ALONE. IN ADDITION, THERE IS A SUSPECT AREA IN THE LEAD BEYOND THE CONNECTOR PIN; HOWEVER, THIS CANNOT BE CONFIRMED DUE TO THE IMAGE QUALITY. THE PRESENCE OF ADDITIONAL MICRO-FRACTURES IN THE LEAD CAN ALSO NOT BE RULED OUT. A PORTION OF THE LEAD APPEARED TO BE BEHIND THE GENERATOR WHICH COULD NOT BE ASSESSED. A DEVICE HISTORY REVIEW FOR THE LEAD AND GENERATOR CONFIRMED BOTH DEVICES MET ALL FINAL TESTING SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT¿S GENERATOR WAS NOT REPLACED DURING SURGERY ON (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT WAS SCHEDULED TO UNDERGO GENERATOR AND LEAD REPLACEMENT SURGERY. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2014 DUE TO HIGH LEAD IMPEDANCE. PRE-OPERATIVE DIAGNOSTIC RESULTS SHOWED HIGH LEAD IMPEDANCE. ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED CONFIRMING THAT THE GENERATOR WAS EXPLANTED THE DAY THE LEAD WAS EXPLANTED. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95515 PULSE GEN MODEL 103 GENERATOR LYJ LIVANOVA USA, INC. 103 3181

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR