BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 580828 · Received March 11, 2005

    Report

    Report Number
    1644487-2005-00169
    Event Type
    Injury
    Date Received
    March 11, 2005
    Date of Event
    February 1, 2005
    Report Date
    February 9, 2005
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    VNS PT'S GENERATOR WAS EXPLANTED DUE TO INFECTION. THE PT WAS EXPERIENCING REDNESS AND IRRITATION AROUND THE GENERATOR AREA, BUT THAT IT WAS NOT INITIALLY BELIEVED TO BE DUE TO INFECTION. THE GENERATOR THEN BEGAN TO PROTRUDE QUITE A BIT AND THE SKIN WAS VERY THIN OVER THE GENERATOR, WHICH WAS ABNORMAL FOR THE PT. TREATING SURGEON WAS PLANNING ON PERFORMING GENERATOR REPLACEMENT SURGERY, BUT DISCOVERED THE INFECTION AT THE TIME OF SURGERY. UPON OPENING THE CHEST POCKET, THE SURGEON DISCOVERED A SMALL AMOUNT OF PUS. UPON REMOVING THE LEAD CONNECTOR PINS FROM THE GENERATOR, A RUSTY-COLORED SUBSTANCE APPEARED TO BE PRESENT ON THE POSITIVE CONNECTOR PIN. ADD'L, THE LEAD SILICONE APPEARED TO BE SLIGHTLY DISCOLORED (YELLOW) NEAR THE CONNECTOR PIN. A YELLOWISH LIQUID SUBSTANCE APPEARED TO BE PRESENT AT THE BOTTOM OF THE POSITIVE RECEPTABLE HOLE OF THE GENERATOR. THE CONNECTOR PINS WERE CLEANED OFF AND LEFT IN PLACE. THE CONNECTOR PINS APEARED TO BE IN GOOD CONDITION AFTER BEING CLEANED, THOUGH THE LEAD WAS STILL SLIGHTLY DISCOLORED. THE ORIGINAL GENERATOR WAS EXPLANTED, LEAVING THE LEAD IN SITU. A REPLACEMENT GENERATOR HAS NOT BEEN IMPLANTED TO DATE. THE INFECTION HAS REPORTEDLY RESOLVED. REVIEW OF MANUFACTURING RECORDS FOR BOTH THE PULSE GENERATOR AND THE BIPOLAR LEAD REVEALED NO ANOMALIES THAT WOULD ADVERSELY EFFECT DEVICE PERFORMANCE AND CONFIRMED STERILIZATION OF DEVICES. THERE IS NO EVIDENCE AT THIS 1 ME THAT THE NCP SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 5757

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R MODEL 300-20 NCP BIPOLAR LEAD,| DATE OF MFG 03/2002,| STERILIZATION LOT NO. 5423| EXPIRED DATE: 02/2004,