BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2504330 · Received March 26, 2012

    Report

    Report Number
    1644487-2012-00820
    Event Type
    Death
    Date Received
    March 26, 2012
    Date of Event
    October 17, 2011
    Report Date
    June 25, 2018
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A DEATH INVESTIGATOR THAT THE PATIENT PASSED AWAY ON (B)(6) 2011. AT THE TIME OF THE REPORT THE CAUSE OF DEATH WAS UNKNOWN AS WAS THE RELATIONSHIP OF BETWEEN THE PATIENT'S DEATH AND VNS. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    AN OBITUARY FOR THE PATIENT WAS LOCATED AND INDICATED THAT THE PATIENT PASSED AWAY IN A HOSPITAL. ATTEMPTS FOR PRODUCT RETURN FROM THE PATIENT'S FUNERAL HOME WERE UNSUCCESSFUL AS THE PRODUCTS WERE NOT EXPLANTED. ATTEMPTS TO OBTAIN A DEATH CERTIFICATE WERE ALSO UNSUCCESSFUL AS THE VITAL RECORDS DEPARTMENT INDICATED THAT THEY COULD NOT DISCLOSE THAT INFORMATION TO THE MANUFACTURE AS IT IS NOT A FAMILY MEMBER. A SUDEP EVALUATION ON THIS PATIENT'S DEATH WAS PERFORMED AND IT WAS DETERMINED NOT TO BE SUDEP. A ROUGH ESTIMATION OF GENERATOR BATTERY LIFE WAS ALSO PERFORMED AND BASED ON THE PATIENT'S LAST KNOWN SETTINGS, THE GENERATOR WOULD NOT BE EXPECTED TO BE AT END OF SERVICE AT THE TIME OF THE PATIENT'S DEATH. ATTEMPTS FOR THE PATIENT'S CAUSE OF DEATH AND ITS RELATIONSHIP TO VNS HAVE REMAINED UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    A MEDICAL EXAMINER REPORTED THE PATIENT'S DEATH AND WANTED TO RETURN THE EXPLANTED DEVICE. THE PATIENT'S CAUSE OF DEATH WAS REPORTED TO BE ANOXIC ENCEPHALOPATHY AND IT WAS MENTIONED THAT THE DEATH WAS NOT RELATED TO VNS THERAPY. THE EXPLANTED DEVICES WERE RECEIVED BUT PRODUCT ANALYSIS HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    THE DEVICE WAS EXPLANTED AND RETURNED DUE TO DEATH OF THE PATIENT. IN THE LAB, 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 IN THE PA LAB CONCLUDED PROPER FUNCTIONALITY OF THE PULSE GENERATOR AND THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND. A LARGE PORTION OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODES WAS NOT RETURNED FOR ANALYSIS; THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. THE ABRADED OPENINGS FOUND AND SLICE MARKS FOUND ON THE OUTER SILICONE TUBING AND THE CUT ENDS THAT WERE MADE DURING THE EXPLANTED PROCESS, MOST LIKELY PROVIDED THE LEAKAGE PATH FOR THE DRIED REMNANTS OF WHAT APPEARED TO HAVE ONCE BEEN BODY FLUIDS INSIDE THE OUTER SILICONE TUBING. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED. BASED ON THE FINDINGS IN THE LAB, THERE IS NO EVIDENCE TO SUGGEST AN ANOMALY WITH THE RETURNED PORTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ LIVANOVA USA, INC. 102 013834

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Death