BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2781088 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13332
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 2, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL RESOLUTION HAS BEEN REQUESTED FROM THE FIELD REPRESENTATIVE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE FIELD REPRESENTATIVE HAD NO FURTHER INFORMATION AND RECORDS INDICATE THIS LEAD REMAINS IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS HAVING A ELECTROCARDIOGRAM FOR PREMATURE VENTRICULAR CONTRACTIONS AT THEIR FAMILY PHYSICIAN'S PRACTICE. AT THAT TIME THEIR RIGHT ATRIAL (RA) LEAD WAS IDENTIFIED TO BE FRACTURED WITH IMPEDANCES GREATER THAN 2500 OHMS AND INAPPROPRIATE SENSING. THIS DID NOT CAUSE ANY SYMPTOMS OR ADVERSE PATIENT EFFECTS AND THE PATIENT WAS FURTHER REFERRED TO THEIR CARDIOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR 4470| 1297| 223-01| 4469| MISMATCH