BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2990923 · Received March 6, 2013

    Report

    Report Number
    1644487-2013-00599
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    September 28, 2012
    Report Date
    February 6, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE, CORRECTED DATA: ADDITIONAL INFORMATION WAS RECEIVED INDICATING WHEN THE INFECTION WAS FIRST OBSERVED. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS FIELD.

    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

    AN IMPLANT CARD WAS RECEIVED INDICATING THAT THIS VNS PATIENT UNDERWENT GENERATOR REVISION ON (B)(6) 2013 DUE TO INFECTION. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. A REVIEW OF DEVICE HISTORY RECORDS SHOWED THAT BOTH THE LEAD AND GENERATOR WERE STERILIZED PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    THE INFECTION WAS FIRST SEEN ON (B)(6) 2012. THE INFECTION WAS A POSTOPERATIVE COMPLICATION THAT APPEARED IN THE AREA OF THE IMPLANT. THERE WAS POOR SCAR CARE POSTOPERATIVELY BY REPEATED DIRECT MANIPULATION BY THE PATIENT DUE TO SEVERE COGNITIVE DELAY NOT CONTROLLED BY THE FAMILY. CLINICAL DATA APPEARED CONSISTENT WITH INTRACLAVICULAR SCAR INFECTION THAT RESOLVED AFTER DEBRIDEMENT AND ANTIBIOTICS. THERE WAS NO EVIDENCE TO DATE OF INFECTION IN OTHER LOCATIONS. CULTURES FROM THE GENERATOR SITE SHOWED GROWTH OF (B)(6). DURING SURGERY, THE GENERATOR WAS REMOVED, THE SURGICAL SITE WAS WASHED, LEAD PIN PLACEMENT WAS SHIFTED AWAY FROM THE INFECTED POCKET, AND THE PATIENT WAS PRESCRIBED IV ANTIBIOTICS IV FOR 2 WEEKS FOLLOWED BY 4 WEEKS OF ORAL ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95968 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202053

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention