BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2850811 · Received November 29, 2012

    Report

    Report Number
    1644487-2012-03139
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    September 9, 2012
    Report Date
    November 1, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. DATE OF EVENT, CORRECTED DATA: ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT WAS FIRST OBSERVED ON (B)(6) 2012. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA.

    Description of Event or Problem · 1

    A LOCAL PARTNER IN (B)(6) REPORTED THAT A CHILD HAD AN ALLERGIC REACTION. THEIR VNS WAS IMPLANTED (B)(6) 2012. THE SURGEON HAS DECIDED TO REMOVE THE GENERATOR. REDNESS SWELLING AND DRAINAGE WAS NOTED AT THE LEAD SITE AND DISCOLORATION AT THE CHEST SITE. NO EXPLANT DATE HAS BEEN PROVIDED AT THIS TIME AND UNKNOWN IF HAS ALREADY HAPPENED. THE PATIENT'S SURGEON DOES NOT KNOW THE CAUSE OF THE EVENT AT THIS TIME AND WILL EVALUATE FURTHER AT EXPLANT. IT IS POSSIBLE THIS IS AN INFECTION EVENT AND THE PHYSICIAN WILL ACCESS FURTHER AT THE TIME OF SURGERY. THE PATIENT DID NOT HAVE A MEDICAL HISTORY OF ALLERGIES PRIOR TO THE IMPLANT. FURTHER INFORMATION WILL BE ATTAINED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT'S DEVICE WAS EXPLANTED, THERE WAS NO SERIOUS INJURY, AND THE WOUND SITE HAD STARTED TO HEAL. THE PHYSICIAN STATED THAT THEY WOULD RE-IMPLANT THE DEVICE IF THERE WAS NO INFECTION AT THE LEAD SITE; HOWEVER, BECAUSE THERE WAS AN INFECTION AT THE LEAD SITE, REPLACEMENT WAS ON HOLD. FURTHER FOLLOW-UP SHOWED THAT THE SURGEON ALSO INDICATED THAT THE PATIENT HAD NO INJURY. AFTER REMOVING THE VNS, THE ALLERGY STOPPED. THE SURGEON DID NOT BELIEVED THAT THE ALLERGY WAS CAUSED BY VNS: THE PATIENT HAS A GENETIC ALLERGY TO OTHER MATERIALS. THE PATIENT WOULD NOT BE REIMPLANTED. THE INFECTION WAS FIRST OBSERVED ON (B)(6) 2012. THE LEAD WAS ALSO EXPLANTED AND ANTIBIOTICS WERE ALSO ADMINISTERED. THE INFECTION WAS NOT BELIEVED TO BE RELATED TO VNS. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT WAS BELIEVED TO HAVE CAUSED/CONTRIBUTED TO THE INFECTION. CULTURES WERE TAKEN FOUR TIMES, BUT NOTHING WAS OBSERVED. THE DEVICES WERE EXPLANTED ON (B)(6) 2012, AND WOULD NOT BE RETURNED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED THAT BOTH THE LEAD AND GENERATOR WERE STERILIZED PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2709

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization| R