BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1953514 · Received January 5, 2011

    Report

    Report Number
    1644487-2011-02965
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    November 21, 2010
    Report Date
    November 11, 2019
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    MFR REPORT #1644487-2014-00514 WAS INADVERTENTLY CREATED AND USED TO SUBMIT VERSION 4. THE CORRECT MFR REPORT # FOR VERSION 4 IS MFR REPORT # 1644487-2011-02965. MFR REPORT #1644487-2014-00514 SHOULD NOT HAVE BEEN CREATED FOR THE REPORT.

    Additional Manufacturer Narrative · 1

    MFR REPORT #1644487-2014-00514 WAS INADVERTENTLY CREATED AND USED TO SUBMIT VERSION 5. THE CORRECT MFR REPORT # FOR VERSION 5 IS MFR REPORT # 1644487-2011-02965. MFR REPORT #1644487-2014-00514 SHOULD NOT HAVE BEEN CREATED FOR THE REPORT.

    Description of Event or Problem · 1

    THE REPORTER REVEALED THE INFECTION WAS DUE TO POOR HYGIENE AND PICKING AT THE INCISION SITE. THE PATIENT HAS NOT FOLLOWED BACK UP WITH THE REPORTER. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN, AS THE PATIENT HAS BEEN NON-COMPLIANT IN KEEPING OFFICE APPOINTMENTS PER THE TREATING NEUROLOGIST. THE NEUROLOGIST'S OFFICE HAS BEEN ATTEMPTING TO CONTACT THE PATIENT FOR EVALUATION, BUT THIS HAS BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT HAD THE VNS GENERATOR AND LEAD REMOVED DUE TO INFECTION. THE PATIENT HAD PICKED AT HER GENERATOR SITE WOUND AND THIS CONTRIBUTED TO THE INFECTION. THE PATIENT IS ALSO ON A COURSE OF ANTIBIOTICS PRESCRIBED BY A DIFFERENT PHYSICIAN. THE REPORTER HAS NOT SEEN THE PATIENT SINCE THE VNS EXPLANT SURGERY OCCURRED.

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT'S INFECTION CAUSED THE PATIENT TO HAVE AN INCREASE IN SEIZURES. THE INCREASED SEIZURES EVENT WAS PREVIOUSLY REPORTED VIA MDR #1644487-2011-00629.

    Description of Event or Problem · 1

    RPTR INDICATED A RECENTLY IMPLANTED VNS PT DEVELOPED AND INFECTION AT THE VNS INCISION SITE (BELIEVED TO BE THE GENERATOR SITE IN THE CHEST) AND REQUIRED DEBRIDEMENT AND DRAINAGE OF THE SITE. THE PT WAS PLACED ON INTRAVENOUS ANTIBIOTICS, AND THEN DISCHARGED HOME WITH TWO WEEKS OF ANTIBIOTICS. THE INCISION SITE IS CURRENTLY CLEAN AND DRY. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ LIVANOVA USA, INC. 102 2701

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention