BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210862 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06863
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    March 20, 2013
    Report Date
    August 2, 2013
    Manufacturer
    CPI PLANT - ST. PAUL
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, INITIAL ANALYSIS WAS PERFORMED REVEALING THE DISTAL HIGH VOLTAGE CABLE IS FRACTURED AT 30.2 MM FROM THE TERMINAL PIN AND THE DISTAL SIDE OF THE FRACTURE IS AT 34.0 MM FROM THE TERMINAL PIN. FURTHER ANALYSIS WILL BE PERFORMED TO DETERMINE THE ROOT CAUSE OF THIS FRACTURE.

    Additional Manufacturer Narrative · 1

    FURTHER DETAILED ANALYSIS WAS PERFORMED. THE CABLE WIRES REVEALED EVIDENCE OF CRACKS TYPICALLY SEEN ON WIRES OF THE CABLE THAT ARE BENT. ANALYSIS CONCLUDED THIS LIKELY OCCURRED AS A RESULT OF THE LEAD BENT MULTIPLE TIMES WHEN THE LEAD WAS INSERTED INTO THE DEVICE HEADER DURING THE IMPLANT. SET SCREW MARKS ON THE TERMINAL PIN INDICATE THAT THE LEAD HAD NOT BEEN FULLY INSERTED INTO THE DEVICE HEADER. THE LEAD TERMINAL AREA MEASURES IN SPECIFICATION. THIS SUGGESTS THAT A MANUFACTURING ISSUE WITH THE LEAD ITSELF DID NOT CONTRIBUTE TO THE ALLEGATION OF INSERTION DIFFICULTY AND THE FRACTURE WAS INDUCED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, WHEN THIS RIGHT VENTRICULAR LEAD WAS INSERTED INTO THE NON-BOSTON SCIENTIFIC DEVICE HEADER, THIS LEAD DID NOT FIT INTO THE HEADER OF THE DEVICE. A FURTHER ATTEMPT WITH ANOTHER NON-BOSTON SCIENTIFIC DEVICE WAS ALSO UNSUCCESSFUL. THE LEAD COULD NOT BE ADVANCED FAR ENOUGH INTO THE DEVICE HEADER. X-RAYS WERE TAKEN OF THIS ISSUE. FINALLY A NON-BOSTON SCIENTIFIC SHOCK LEAD WAS SUCCESSFULLY INSERTED INTO THE DEVICE HEADER. THIS LEAD WAS REMOVED AND WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    - -

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309313 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI PLANT - ST. PAUL 0692

    Patients

    Seq Age Sex Outcome Treatment
    1