BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 4164211 · Received October 10, 2014

    Report

    Report Number
    1644487-2014-02644
    Event Type
    Death
    Date Received
    October 10, 2014
    Date of Event
    November 11, 2008
    Report Date
    September 12, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THIS INFORMATION WAS INADVERTENTLY LEFT OFF OF FOLLOW-UP MFR. REPORT #01.

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. THE PHYSICIAN DID NOT HAVE ANY ADDITIONAL RELEVANT INFORMATION. THE CAUSE AND DATE OF DEATH ARE UNKNOWN. THE RELATIONSHIP OF THE CAUSE OF DEATH TO VNS IS UNKNOWN. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    HOSPITAL RECORDS WERE RECEIVED INDICATING THAT THE PATIENT'S PRIMARY DIAGNOSIS WAS STATUS EPILEPTICUS. THE SECONDARY DIAGNOSES WERE LISTED AS DISSEMINATED INTRAVASCULAR COAGULATION, CARDIOPULMONARY ARREST, SEIZURE DISORDER, HYDROCEPHALUS, RESPIRATORY FAILURE, MENTAL RETARDATION, AND CEREBRAL PALSY. THE PATIENT'S PAST MEDICAL HISTORY WAS LISTED AS SEIZURE DISORDER, HYDROCEPHALUS WITH VP SHUNT, (B)(6) STATUS POST DECOMPRESSION AND MRCP. IT WAS NOTED THAT THE PATIENT WAS FOUND DURING SLEEP TO HAVE SEIZURE ACTIVITY AND DIASTAT WAS GIVEN WITH NO IMPROVEMENT. THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM WITH FEVER, INCREASED HEART RATE TO 200 AND LOW BLOOD PRESSURE (74/42). LABS WERE TAKEN AND THE PATIENT HAD AN INCREASED PT, PTT AND INR. BLOOD GASES SHOWED THE PATIENT WAS ACIDOTIC AND HAVING WORSENING RESPIRATORY DISTRESS INCLUDING METABOLIC AND RESPIRATORY ACIDOSIS SO THE PATIENT WAS INTUBATED. THE PATIENT BECAME HYPOTENSIVE AND BLEEDING FROM THE MOUTH. THE PATIENT DEVELOPED LARGE HEMATOMAS AT MULTIPLE SITES WHERE BLOOD WAS DRAWN. THE PATIENT RECEIVED FRESH FROZEN PLASMA AND WAS PLACED ON VENTILATOR SUPPORT. METABOLIC ACIDOSIS CONTINUED AND THE PATIENT WAS GIVEN SODIUM BICARB. THE PATIENT'S HEART RATE DROPPED AND THE PATIENT BECAME PULSELESS. CPR WAS INITIATED ALONG WITH DEFIBRILLATION. THE PATIENT'S FAMILY REQUESTED WITHDRAWAL OF SUPPORT.

    Description of Event or Problem · 1

    THE PATIENT'S ONLINE OBITUARY INDICATED THAT THE PATIENT PASSED AWAY AT THE HOSPITAL. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639906 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS, INC. 101 4244

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Death