BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 4935933 · Received July 23, 2015

    Report

    Report Number
    1644487-2015-05305
    Event Type
    Injury
    Date Received
    July 23, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 2, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    PRODUCT ANALYSIS FOR THE GENERATOR WAS COMPLETED AND APPROVED ON 07/29/2015. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. PRODUCT ANALYSIS FOR THE LEAD WAS COMPLETED AND APPROVED ON 08/10/2015. AN ANALYSIS WAS PERFORMED ON THE RETURNED LEAD PORTIONS OF THE LEAD. A LARGE PORTION OF THE LEAD ASSEMBLY (BODY) WAS NOT RETURNED FOR ANALYSIS; THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. THE CONDITION OF THE RETURNED LEAD PORTIONS IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2015 THAT A PATIENT HAD UNDERGONE GENERATOR AND PARTIAL LEAD EXPLANT DUE TO INFECTION. THE EXPLANTED GENERATOR AND LEAD WERE RECEIVED FOR ANALYSIS ON 07/08/2015. IT WAS REPORTED THAT THE INFECTION WAS PRESENT AT BOTH THE GENERATOR AND ELECTRODE SITES. THE BELIEVED CAUSE WAS DUE TO PATIENT MANIPULATION OF THE WOUND 2 YEARS AFTER SURGERY. PRODUCT ANALYSIS IS CURRENTLY UNDERWAY BUT HAS NOT BEEN COMPLETED AND APPROVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478390 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 3592

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention