BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3843719 · Received June 2, 2014

    Report

    Report Number
    1644487-2014-01392
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    April 25, 2014
    Report Date
    March 23, 2018
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE GENERATOR SITE. THE SURGEON PLANNED ON TAKING OUT THE GENERATOR AND "WIPING IT OFF". FURTHER FOLLOW-UP REVEALED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT AT WHICH TIME THE NEW GENERATOR WAS IMPLANTED ON THE PATIENT'S RIGHT SIDE OF THE CHEST. IT WAS REPORTED THAT THE INFECTION WAS OBSERVED RIGHT AFTER THE IMPLANT SURGERY. NO CULTURES WERE PERFORMED.

    Description of Event or Problem · 1

    ADDITIONAL DETAILS WERE RECEIVED REGARDING PATIENT'S INFECTION. PATIENT HAD A SURGICAL WOUND INFECTION WITH (B)(6). PATIENT DID NOT RESPOND TO IV ANTIBIOTICS WITHOUT REMOVAL OF THE DEVICE. HE WAS LEFT WITHOUT THE DEVICE FOR SOME TIME. PATIENT HAD A PICC LINE WITH PROLONGED ANTIBIOTIC TREATMENT AND THE INFECTION WAS ELIMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321940 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202425

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention