BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAINOX SL 65/18

    MDR report key: 3083062 · Received April 29, 2013

    Report

    Report Number
    1028232-2013-01132
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Additional Manufacturer Narrative · 1

    2/16/15 - CORRECTED THE MANUFACTURE DATE. UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS FOUND DISSECTED. ONLY THE PROXIMAL FRAGMENTS WERE RECEIVED FOR ANALYSIS. IT IS REASONABLE TO ASSUME THAT THE LEAD WAS DISSECTED IN THE COURSE OF THE SURGERY. THE CUT WAS DONE AT APPROX. 7 CM PROXIMAL TO THE CONNECTOR PINS. THE YOKE WAS NOT INCLUDED. THE RETURNED LEAD FRAGMENTS WERE ANALYZED. THE VISUAL INSPECTION REVEALED THAT THE INSULATION WAS, APART FROM THE PRESENT CUTTINGS, FREE OF BREACHES. FURTHER ANALYSIS OF THE LEAD DID NOT REVEAL ANY IRREGULARITY THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED CLINICAL EVENT. THE ANALYSIS OF THE AVAILABLE LEAD FRAGMENTS DID NOT REVEAL ANY INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD IS DISPLAYING NOISE. THERE IS NO INDICATION THAT THE LEAD HAS BEEN REMOVED, NOTES INDICATE THAT THE LEAD IS BEING MONITORED. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183600 KAINOX SL 65/18 ICD LEAD NVY BIOTRONIK SE & CO. KG 124237

    Patients

    Seq Age Sex Outcome Treatment
    1 Other