BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1202925 · Received October 17, 2008

    Report

    Report Number
    1644487-2008-02489
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 23, 2019
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFG RECORDS WERE REVIEWED. REVIEW OF MFG RECORDS CONFIRMED STERILIZATION FOR THE GENERATOR PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS NOT LATE, AS SUPPLEMENTAL REPORT# 2 WAS UNABLE TO BE SUBMITTED USING MFR REPORT # 1644487-2008-02489 DUE TO TECHNICAL ISSUES EXPERIENCED WITH THE EMDR SYSTEM. SUPPLEMENTAL REPORT #2 WAS PREVIOUSLY SUBMITTED USING MFR REPORT # 1644487-2019-00458 AS AN INITIAL REPORT, BUT ALL FUTURE SUPPLEMENTAL REPORTS WILL BE SUBMITTED USING MFR REPORT #1644487-2008-02489.

    Description of Event or Problem · 1

    RPTR INDICATED THAT THE PT HAD AN ASEPTIC INFECTION AT THE GENERATOR SITE. PER PHYSICIAN, THE CAUSE IS UNK AND NO INTERVENTIONS WERE TAKEN, AS PT SPONTANEOUSLY RECOVERED.

    Description of Event or Problem · 1

    PER THE REPORTER, THE PATIENT HAD HIS VNS DEVICE EXPLANTED AND REPLACED ON (B)(6) 2008 DUE TO GENERATOR END -OF-SERVICE. PRODUCT HAS BEEN REQUESTED, BUT HAS NOT BEEN RETURNED TO DATE.

    Description of Event or Problem · 1

    A SCIENTIFIC ARTICLE WAS RECEIVED WHICH DISCUSSED THE PATIENT¿S HISTORY WITH THE VNS DEVICE. THE ARTICLE DISCUSSES THE REPLACEMENT SURGERY OF THE PATIENT'S M102 GENERATOR, AND THAT DURING THIS SURGERY A DISCONNECTION BETWEEN THE LEAD AND THE GENERATOR WAS OBSERVED. THIS DISCONNECTION IS REPORTED ON MFR. REPORT #1644487-2008-01785. THERE WAS NO MENTION OF THE PREVIOUSLY REPORTED INFECTION IN THE ARTICLE. THIS REPORT IS A CONTINUATION OF MEDWATCH MFR REPORT # 1644487-2008-02489. NO ADDITIONAL OR RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 NONE LYJ LIVANOVA USA, INC. 102 014788

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening