BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2871752 · Received December 13, 2012

    Report

    Report Number
    1644487-2012-03329
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    December 3, 2012
    Report Date
    February 16, 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
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH.

    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)(6) 2013 WHEN A COPY OF THE PATIENT'S X-RAYS WERE RECEIVED FOR REVIEW BY THE MANUFACTURER. THE LEAD PINS APPEARED TO BE FULLY INSERTED INTO THE GENERATOR. THE LEAD WIRE ALSO APPEARED TO BE INTACT AT THE LOCATION OF THE CONNECTOR PINS. THERE WAS A PORTION OF THE LEAD LOCATED BEHIND THE GENERATOR THAT COULD NOT BE ASSESSED. THE ELECTRODE PLACEMENT APPEARED NORMAL. THERE DID NOT APPEAR TO BE ANY LEAD DISCONTINUITIES OR SHARP ANGLES IN THE LEAD PORTION THAT WAS ABLE TO BE VISUALIZED. BASED ON THE X-RAY IMAGES PROVIDED, NO CAUSE FOR THE REPORT OF HIGH IMPEDANCE COULD BE FOUND. HOWEVER, A PORTION OF THE LEAD COULD NOT BE ASSESSED DUE TO IT BEING LOCATED BEHIND THE GENERATOR AND THE PRESENCE OF A MICRO-FRACTURE IN THE LEAD CANNOT BE RULED OUT. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN WERE UNSUCCESSFUL. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2012 IT WAS REPORTED THAT THE PATIENT RECENTLY UNDERWENT A BATTERY REPLACEMENT SURGERY ON (B)(6) 2012 AND AT THE TIME OF SURGERY, THE IMPEDANCE WAS 4582 OHMS BUT ON SUBSEQUENT FOLLOW-UP APPOINTMENTS THE IMPEDANCE HAS BEEN HIGH WITH A VALUE OF 8030 OHMS. THE PHYSICIAN REPORTED THAT THE LEAD DOES NOT APPEAR TO BE BROKEN. THE PATIENT REPORTED WORSENED SEIZURES BUT ONLY AFTER HE WAS TOLD OF THE HIGH IMPEDANCE. ATTEMPTS FOR ADDITIONAL INFORMATION ARE UNDERWAY BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-20 1071

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR