BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304

    MDR report key: 3854244 · Received June 6, 2014

    Report

    Report Number
    1644487-2014-01417
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 3, 2014
    Report Date
    February 20, 2019
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THIS DATE ON FOLLOW-UP MFR. REPORT #03 INADVERTENTLY REPORTED THE INCORRECT YEAR. THE DATE SHOULD HAVE BEEN REPORTED AS 07/28/2014. THE REPORT WAS NOT A LATE SUBMISSION.

    Additional Manufacturer Narrative · 1

    NEW INFORMATION CHANGES THE SUSPECT DEVICE.

    Additional Manufacturer Narrative · 1

    THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY DID NOT INCLUDE INFORMATION REGARDING THE REASON FOR LEAD REPLACEMENT SURGERY AND THE PATIENT¿S ACID REFLUX. THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY DID NOT INCLUDE THAT NO DEVICE FAILURE IS BELIEVED TO HAVE OCCURRED AS DIAGNOSTIC RESULTS SHOWED NORMAL DEVICE FUNCTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT UNDERWENT LEAD REPLACEMENT SURGERY ON (B)(6) 2014. THE PATIENT¿S GENERATOR WAS NOT REPLACED. THE EXPLANTED LEAD HAS NOT BEEN RETURNED TO DATE. FURTHER FOLLOW-UP REVEALED THAT THE PATIENT¿S DEVICE WAS TESTED DURING AN OFFICE VISIT ON (B)(6) 014 AND DIAGNOSTIC RESULTS SHOWED NORMAL DEVICE FUNCTION. THE PATIENT WAS CONCERNED THAT THERE WAS A POTENTIAL RELATIONSHIP BETWEEN VNS AND THE PATIENT¿S ACID REFLUX. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, DESPITE NORMAL DIAGNOSTIC RESULTS, THE VNS PATIENT¿S LEAD WAS REPLACED DUE TO THE PATIENT¿S INCREASE IN SEIZURES FOLLOWING THE MOTOR VEHICLE ACCIDENT. FURTHERMORE, IT WAS REPORTED THAT THE PATIENT DID NOT HAVE A HISTORY OF ACID REFLUX. THE REPORTED ACID REFLUX IS BELIEVED TO BE RELATED NOT TO STIMULATION BUT TO THE PATIENT¿S PSYCHOSOMATIC ISSUES. LEAD REPLACEMENT SURGERY OCCURRED PRIOR TO THE ONSET OF THE ACID REFLUX.

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED INDICATING THAT THE VNS PATIENT WAS IN A CAR ACCIDENT ON (B)(6) 2014 AND SUSTAINED A NECK INJURY. THE PATIENT HAD NECK PAIN AND IMMEDIATELY HAD A SEIZURE FOLLOWING THE CAR ACCIDENT. THE PATIENT HAD BEEN SEIZURE FREE FOR NEARLY A YEAR PRIOR TO THE CAR ACCIDENT. THE PATIENT¿S DEVICE SETTINGS WERE INCREASED DURING AN OFFICE VISIT ON (B)(6) 2014. THE PATIENT¿S NECK PAIN WORSENED WITH STIMULATION. THE PATIENT BEGAN HAVING HEAD AND EAR PAIN. THE PATIENT ALSO BEGAN EXPERIENCING VOICE HOARSENESS, OCCASIONAL DROOLING, AND HEAD TILTING WITH STIMULATION. (THE PATIENT PULLED HER NECK TOWARD HER CHEST DURING DEVICE ON-TIMES.) X-RAYS WERE TAKEN AND WERE REPORTED BY THE PHYSICIAN TO BE UNREMARKABLE. THE PATIENT¿S DEVICE SETTINGS WERE DECREASED DURING AN OFFICE VISIT ON (B)(6) 2014. THE PATIENT SUBSEQUENTLY HAD FOUR GENERALIZED CONVULSIONS WITHIN 24 HOURS. THE PATIENT¿S DEVICE SETTINGS WERE INCREASED DURING AN OFFICE VISIT ON (B)(6) 2014 AND THE PATIENT WAS ABLE TO TOLERATE HER ADJUSTED DEVICE SETTINGS. THE PATIENT WAS REFERRED FOR SURGERY BUT NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR WAS RECEIVED FOR ANALYSIS. PRODUCT ANALYSIS FOR THE GENERATOR WAS COMPLETED AND APPROVED. THE GENERATOR WAS EXPLANTED FOR PROPHYLACTIC REASONS. THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. ANALYSIS CONCLUDED PROPER FUNCTIONALITY OF THE PULSE GENERATOR AND THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S SYMPTOMS RESOLVED AFTER LEAD REPLACEMENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332829 LEAD MODEL 304 LEAD LYJ LIVANOVA USA, INC. 304-20 3429

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention