BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2870593 · Received December 12, 2012

    Report

    Report Number
    1644487-2012-03311
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 14, 2012
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OF HIGH LEAD IMPEDANCE AND INCREASED SEIZURES IS A SERIOUS INJURY AND A MALFUNCTION. THE SUSPECT DEVICE IS THE LEAD, NOT THE GENERATOR, AS HIGH LEAD IMPEDANCE WAS NOTED WITH THE RESIDENT LEAD AND NEW GENERATOR ON (B)(6) 2012. OVERALL REPORTABILITY OF THE EVENTS IS A MALFUNCTION. DEVICE FAILURE IS SUSPECTED.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED VNS GENERATOR WAS COMPLETED. AN OPEN CAN MEASUREMENT OF THE BATTERY VOLTAGE DETERMINED THAT THE BATTERY WAS DEPLETED. THE END OF SERVICE CONDITION WAS THE RESULT OF NORMAL, EXPECTED BATTERY DEPLETION BASED ON THE BATTERY LIFE CALCULATION, THE ELECTRICAL TEST RESULTS AND THE BENCH EVALUATION. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS OF THE CURRENT AUTOMATED POST BURN-IN TEST. ANALYSIS OF THE GENERATOR IN THE PA LAB CONCLUDED THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND WITH THE GENERATOR. ALL ATTEMPTS TO THE REPORTER FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. REVISION SURGERY APPEARS TO STILL BE PLANNED, BUT NO SURGERY DATE HAS BEEN SCHEDULED.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(4) 2012, RECEIVED TO THE MANUFACTURER FROM THE REPORTER INDICATING THAT A VNS PATIENT WAS EXPERIENCING WORSENING SEIZURES. MEDICATION WAS INCREASED, AND THE PATIENT HAS BEEN REFERRED FOR VNS GENERATOR REPLACEMENT, BUT SURGERY HAS NOT OCCURRED TO DATE. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT HAD VNS GENERATOR REPLACEMENT SURGERY PERFORMED ON (B)(6) 2012. THE GENERATOR WAS UNABLE TO BE INTERROGATED PREOPERATIVELY DUE TO END OF SERVICE. WHEN THE NEW VNS GENERATOR WAS CONNECTED TO THE RESIDENT LEAD, HIGH LEAD IMPEDANCE RESULTED. REINSERTING THE LEAD PIN DID NOT RESOLVE THE HIGH LEAD IMPEDANCE, RULING OUT A LEAD PIN INSERTION ISSUE AND MAKING A LEAD FRACTURE MORE LIKELY. THE LEAD WAS NOT REPLACED, AND THE NEW GENERATOR WAS IMPLANTED BUT PROGRAMMED OFF. THE PLAN OF CARE IS TO SEEK VNS LEAD AND GENERATOR REVISION SURGERY AT A LATER DATE. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS. THE EXPLANTED GENERATOR HAS BEEN RETURNED AND IS PENDING ANALYSIS.

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT HAD VNS GENERATOR AND LEAD REPLACEMENT SURGERY PERFORMED ON (B)(6) 2013. THE EXPLANTED DEVICES WILL NOT BE RETURNED FROM THE HOSPITAL PER HOSPITAL POLICY.

    Description of Event or Problem · 1

    REPORTER INDICATED SURGERY TO REPLACE THE VNS LEAD AND GENERATOR WAS SCHEDULED FOR (B)(6) 2013 BUT CANCELED. THE SURGERY HAS BEEN TENTATIVELY RESCHEDULED FOR (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-20 4105

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention