BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 6805431 · Received August 18, 2017

    Report

    Report Number
    1644487-2017-04322
    Event Type
    Injury
    Date Received
    August 18, 2017
    Date of Event
    July 11, 2017
    Report Date
    October 4, 2021
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    PRODUCT ANALYSIS WAS COMPLETED ON THE RETURNED GENERATOR. THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE DEVICE WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. THE DEVICE SHOWED SIGNS OF VARIATION IN THE OUTPUT SIGNAL EVERY 24 HOURS AS EXPECTED AT THE SETTINGS PROGRAMMED AND DEMONSTRATED THE EXPECTED LEVEL OF OUTPUT CURRENT. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS COMPLETED ON THE RETURNED LEAD . NOTE THAT A SIGNIFICANT PORTION OF THE LEAD (INCLUDING THE ELECTRODE ARRAY) WAS NOT RETURNED FOR ANALYSIS, SO AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. NO DISCONTINUITIES WERE IDENTIFIED WITHIN THE RETURNED LEAD PORTION. OTHER THAN TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED THAT THE PATIENT HAS CONTINUED TO EXPERIENCE PSYCHOSIS ISSUES WHILE THE VNS REMAINED OFF. IT WAS REPORTED THAT THE PATIENT WAS SEIZURE-FREE WITH VNS AND REMAINED SEIZURE-FREE WITH THE VNS TURNED OFF. BECAUSE OF THIS, THE PHYSICIAN NO LONGER BELIEVED THE PSYCHOSIS WAS VNS-RELATED, ALTHOUGH IT WAS NOT KNOWN WHAT CAUSED THE PSYCHOTIC ISSUES. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED THAT THE PHYSICIAN WAS UNABLE TO DRAW A CONCLUSION BETWEEN THE PATIENT'S PRESENTATION OF MUSCLE SPASMS AND FATIGUE/HYPERSOMNOLENCE AND THE FINDING OF THE PATIENT'S UNDERLYING PSYCHOTIC ISSUES. THE PHYSICIAN INDICATED THEY WERE LIKELY SEPARATE EVENTS. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THE PATIENT WAS BEING EXPLANTED AT THE FAMILY'S REQUEST DUE TO THE BEHAVIOR CHANGES (BEING SEDATE) THAT HE EXPERIENCED WHILE STIMULATION WAS ON. CONVERSELY, THE DOCTOR INDICATED THAT THE BEHAVIOR WAS BETTER. LATER INFORMATION WAS RECEIVED THAT THE PATIENT HAD DECREASED FOOD INTAKE AT EVEN LOW SETTINGS. IT WAS REPORTED THAT THE HIGH CPK LEVELS THAT OCCURRED JUST AFTER VNS IMPLANT AND THE SECOND TIME THE VNS WAS TURNED ON; HOWEVER THE CPK LEVELS DID NOT ELEVATE WHEN THE VNS WAS TURNED ON A THIRD TIME. IT WAS NOTED THAT THE CPK LEVELS WERE SUSPECTED TO BE RELATED TO THE ANESTHESIA. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S GENERATOR AND LEAD WAS EXPLANTED. THE PHYSICIAN NOTED THAT THE HIGH CPK CAUSED BY NEUROLEPTIC MALIGNANT SYNDROME FROM ANESTHESIA WAS RULED OUT. THE EXPLANTED GENERATOR AND LEAD WERE RECEIVED FOR ANALYSIS, BUT ANALYSIS HAS NOT COMPLETED TO DATE. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    REPORT RECEIVED THAT A PATIENT EXPERIENCED HYPERSOMNOLENCE AND FATIGUE SHORTLY AFTER INITIAL VNS IMPLANT. THE PATIENT WAS REPORTEDLY VERY ACTIVE PRIOR TO VNS, BUT AFTER THERAPY, HE BECAME UNLIKE HIMSELF AND CHOSE TO SLEEP IF THERE WERE NO ACTIVITIES TO DO. THE PATIENT'S PHYSICIAN ALSO REPORTED THAT THE PATIENT MIGHT HAVE A DEFECT IN HIS SEROTONIN PATHWAY WHICH CAUSED THE VNS TO AFFECT HIS SLEEP. THE PATIENT WAS LATER SEEN TO BE IN A CATATONIC STATE. THE PHYSICIAN REPORTEDLY DISABLED NORMAL MODE STIMULATION BUT KEPT THE MAGNET MODE FEATURE ON. SHE SPECULATED THAT THE CHANGE IN BEHAVIOR COULD BE DUE TO FORCED NORMALIZATION. FURTHER INFORMATION WAS RECEIVED FROM THE PHYSICIAN THAT THE PATIENT PRESENTED WITH DELIRIUM AND RIGIDITY WHILE APPEARING CATATONIC. SHE REPORTED THAT SHE WAS LOOKING INTO THE POSSIBILITY OF A NEUROMUSCULAR PROBLEM RELATED TO THE GENERAL ANESTHETIC USED IN VNS SURGERY. THE NORMAL MODE REMAINED OFF. SYSTEM DIAGNOSTICS WERE NOT PROVIDED AND NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED THAT THE VNS WAS TURNED BACK ON. THE PATIENT RETURNED TO THE CLINIC AND WAS REPORTEDLY HALLUCINATING AND PRESENTED WITH A SLIGHT ELEVATION OF CPK. THE PHYSICIAN REPORTED THAT THIS MIGHT HAVE BEEN DUE TO FORCED NORMALIZATION WHICH WAS PREVIOUSLY SPECULATED TO BE CONTRIBUTING TO THE PATIENT'S EARLIER BEHAVIOR. THE DEVICE WAS TURNED BACK OFF AND THE PATIENT WAS PRESCRIBED A LOW DOSE ANTIPSYCHOTIC. NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583092 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention