BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3140631 · Received May 31, 2013

    Report

    Report Number
    1644487-2013-01546
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    March 28, 2013
    Report Date
    May 8, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EXPLANT DATE; CORRECTED DATA: THE CORRECT EXPLANT DATE WAS OBTAINED FROM THE PHYSICIAN.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE VNS PATIENT REPORTED VIA PHONE CALL ON (B)(6) 2013 THAT HE HAD GENERATOR REPLACEMENT SURGERY ON (B)(6) 2013 AND THAT AT A POST-OPERATIVE APPOINTMENT TWO WEEKS LATER THERE WAS AN OBSERVATION OF INFECTION. THE SURGEON IMMEDIATELY PERFORMED EXPLANT OF BOTH LEAD AND GENERATOR, CONFIRMING THE PRESENCE OF (B)(6) INTRAOPERATIVE AS A RESULT OF POST-OPERATIVE INFECTION. THE PATIENT WAS THEN HOSPITALIZED FOR SEVERAL WEEKS FOR AN ANTIBIOTICS REGIMEN. THE PATIENT EXPERIENCED WEIGHT LOSS DURING THIS HOSPITALIZATION. THE SURGEON ATTRIBUTED THE WEIGHT LOSS TO THE LONG-TERM HOSPITAL ADMISSION FOR THE IV ANTIBIOTICS REGIMEN. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THIS IS BELIEVED TO HAVE CAUSED/CONTRIBUTED TO THE (B)(6) INFECTION AND NO FURTHER INTERVENTION HAS BEEN TAKEN SINCE THE EXPLANT SURGERY OR IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241200 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 202283

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R