BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 2133615 · Received June 16, 2011

    Report

    Report Number
    1644487-2011-01355
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 15, 2011
    Report Date
    May 20, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON (B)(6) 2011 THAT THE PT HAD BEEN ADMITTED TO THE HOSPITAL DUE TO AN INFECTION AND WAS SCHEDULED TO HAVE HER GENERATOR EXPLANTED. THE PT HAD BEEN PICKING AT HER INCISION SITE. SHE WAS PREVIOUSLY PROVIDED ORAL ANTIBIOTICS, BUT THE INFECTION DID NOT IMPROVE. ADDITIONAL INFORMATION WAS REC'D FROM THE SURGEON INDICATING THAT THE INFECTION WAS FIRST OBSERVED RIGHT AFTER IMPLANT. CULTURES OF THE INFECTION INDICATED THAT THE INFECTION WAS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. THE INFECTION SITE WAS DESCRIBED AS "GROSSLY PURULENT". THE GENERATOR WAS EXPLANTED, BUT NO OTHER INTERVENTIONS WERE TAKEN OR PLANNED. THE SURGEON AGAIN INDICATED THAT THE PT HAD SCRATCHED OPEN HER INCISION SITE, CAUSING THE INFECTION. THE INFECTION HAS SINCE RESOLVED. MANUFACTURER RECORDS INDICATED THAT BOTH GENERATOR AND LEAD WERE STERILIZED BY HYDROGEN PEROXIDE PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 105 LYJ CYBERONICS, INC. 105 2877

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention