BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 3922931 · Received July 9, 2014

    Report

    Report Number
    1644487-2014-01738
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    February 27, 2007
    Report Date
    August 2, 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
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: CORRECTED DATA; INITIAL MDR INADVERTENTLY SUBMITTED INCORRECT DATE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN (B)(6) 2007 WHERE DEVICE DIAGNOSTICS RESULTED IN HIGH IMPEDANCE. IT WAS REPORTED THAT THE PATIENT WAS NOT SEEN BY THE FACILITY AGAIN. IT WAS REPORTED THAT THE PATIENT WAS SEEN IN (B)(6) AT ANOTHER FACILITY AND DEVICE DIAGNOSTICS SHOWED HIGH IMPEDANCE (DC DC CODE - 7). THE DEVICE WAS FOUND AT 0MA AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT IS SCHEDULED TO SEE THE NEUROLOGIST. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. NO SURGICAL INTERVENTION HAS BEEN PERFORMED TO DATE.

    Description of Event or Problem · 1

    ANTEROPOSTERIOR AND LATERAL CHEST X-RAYS WERE RECEIVED AND REVIEWED AFTER HIGH LEAD IMPEDANCE WAS OBSERVED ON THIS PATIENT¿S DEVICE FROM A SYSTEM DIAGNOSTIC TEST. THE GENERATOR WAS LOCATED IN THE PATIENT¿S UPPER LEFT CHEST. DUE TO THE QUALITY OF THE IMAGE, IT COULD NOT BE ASSESSED IF THE CONNECTOR PIN IS THROUGH THE SECOND CONNECTOR BLOCK. THE FILTER FEEDTHRU WIRES WERE UNABLE TO BE ASSESSED. DUE TO THE IMAGE QUALITY, THE LEAD WAS NOT VISIBLE AND COULD NOT BE ASSESSED. DUE TO THE SCOPE OF THE IMAGE, THE TIE-DOWNS AND STRAIN RELIEF CANNOT BE VISUALIZED IN THE NECK. THEREFORE, NO ASSESSMENT ON TIE-DOWNS AND STRAIN RELIEF CAN BE MADE. IN THE PORTIONS OF THE LEAD VISIBLE, THERE DID NOT APPEAR TO BE ANY GROSS DISCONTINUITIES OR SHARP ANGLES. DUE TO THE QUALITY OF THE IMAGE, IT WAS UNABLE TO BE ASSESSED IF THE LEAD WIRES WERE INTACT AT THE CONNECTOR PINS. THE CAUSE OF THE PATIENT¿S HIGH IMPEDANCE IS NOT ABLE TO BE ASSESSED BASED OFF OF THE X-RAY SHOWN. NOTE THAT THE PRESENCE OF AN INCOMPLETE PIN INSERTION, MICRO-FRACTURE AND/OR A LEAD DISCONTINUITY COULD NOT BE RULED OUT IN THE PORTION OF THE LEAD THAT IS NOT VISIBLE IN THE PROVIDED IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400289 BIPOL LEAD MODEL 300 LEAD LYJ LIVANOVA USA, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR