BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 3011098 · Received March 19, 2013

    Report

    Report Number
    1644487-2013-00731
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    November 28, 2012
    Report Date
    February 18, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT; CORRECTED DATA: THIS INFORMATION WAS INADVERTENTLY REPORTED INCORRECTLY ON INITIAL MFR. REPORT. CORRECTED DATA: THIS INFORMATION WAS INADVERTENTLY LEFT OFF OF FOLLOW-UP MFR. REPORT #01. THE REPORT SHOULD HAVE INDICATED THAT THE REPORT WAS A FOLLOW-UP #01 REPORT.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: NEW INFORMATION RECEIVED CORRECTS THE DATE OF EXPLANT.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS ON THE GENERATOR WAS COMPLETED ON (B)(6) 2013. RESULTS OF DIAGNOSTIC TESTING INDICATED THE DEVICE WAS OPERATING PROPERLY. ELECTRICAL TEST SHOWED THAT THE PULSE GENERATOR WAS OPERATING WITHIN SPECIFICATION. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR. ALL ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S VNS GENERATOR WAS REMOVED DUE TO INFECTION. THE PATIENT WAS GIVEN ANTIBIOTICS AND A RE-IMPLANT OF A NEW GENERATOR IN THE NEAR FUTURE IS POSSIBLE. DEVICE HISTORY RECORD STERILITY WAS REVIEWED AND NO NON CONFORMANCES WERE FOUND. THE VNS GENERATOR WAS RETURNED TO THE MANUFACTURER ON (B)(4) 2013.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE VNS PATIENT WAS RE-IMPLANTED WITH A NEW GENERATOR ON (B)(6) 2014. THE NEW GENERATOR WAS TESTED WITH THE EXISTING LEAD AND DIAGNOSTIC RESULTS SHOWED LEAD IMPEDANCE WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    OPERATIVE NOTES DATED (B)(6) 2013 NOTE THAT THE PATIENT'S WOUND WAS HEALING WELL UNTIL ABOUT TWO DAYS AGO WHEN THE PATIENT'S MOTHER NOTED SOME DRAINAGE. IT WAS NOTED THAT IT WAS UNCERTAIN IF THE CHILD PICKED AT THE INCISION. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND UNDERWENT AN IRRIGATION AND DEBRIDEMENT OF THE LEFT CHEST INCISION AS WELL AS REMOVAL OF THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114090 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 202210

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention