BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 360635 · Received November 7, 2001

    Report

    Report Number
    1644487-2001-00595
    Event Type
    Injury
    Date Received
    November 7, 2001
    Date of Event
    May 1, 2001
    Report Date
    October 8, 2001
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PT WAS EXPLANTED DUE TO A STAPH INFECTION. PT WAS REIMPLANTED AND BECAME INFECTED AGAIN WITH SECOND NCP SYSTEM WHICH WAS ALSO EXPLANTED. FURTHER INVESTIGATION REVEALED THAT APPROX TWO WEEKS AFTER FIRST IMPLANT, THE INCISION IN PT'S NECK STARTED TO OOZE. NCP SYSTEM WAS EXPLANTED AND PT SPENT A FEW DAYS IN HOSPITAL ON IV ANTIBIOTICS UNTIL THE CULTURES CAME BACK POSITIVE FOR SKIN STAPH. PT WAS REIMPLANTED IN 2001 AND WAS DISCHARGED ON A 3-5 DAY SUPPLY OF ANTIBIOTICS. ONE WEEK POST-OPERATIVELY, THE PT'S NECK WAS SWOLLEN. THE PHYSICIAN CHOSE TO WAIT AND SEE IF IT WOULD RESOLVE. THE NECK WOUND DIDN'T HEAL AND THEN THE CHEST OPENED UP ON IT'S OWN. THE NEXT MONTH, THE SECOND NCP SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49667 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention MODEL 300 NCP BIPOLAR LEAD, S/N UNKNOWN.