BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2913739 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00177
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 30, 2012
    Report Date
    January 24, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY IT WAS CONFIRMED THAT THE LEAD APPEARED KINKED AND SHOWED SIGNS OF HAVING BEEN TWISTED WHICH IS CONSISTENT WITH TWIDDLER'S SYNDROME. TWIDDLER'S SYNDROME CAN LEAD TO DISLODGEMENT AND COMPLICATIONS RELATED TO DISLODGEMENT.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    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

    ADDITIONAL INFORMATION REVEALS THAT THIS PATIENT EXHIBITED TWIDDLER'S SYNDROME AND UNDERWENT A REVISION PROCEDURE DUE TO DISLODGEMENT. THE LEAD WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD DISLODGED. THE PATIENT WAS ADMITTED INTO THE HOSPITAL AND WAS FEELING SOME SPASMS IN THEIR STOMACH. THERE WAS A NOTED DROP IN P-WAVES FROM 4.5 TO 0.3, AN INCREASE IN IMPEDANCES TO 620 OHMS AND NON-CAPTURE AT 5 VOLTS AT 2 MILLISECONDS. IT WAS REPORTED THAT THE PHYSICIAN HAD THE PATIENT'S GENERATOR PROGRAMMED TO PACE IN THE VENTRICLE ONLY AND THE PATIENT WAS DISCHARGED AND WAS TO BE RE-EVALUATED IN THE CLINIC AT A LATER DATE. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19694 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L 0296| E142| 4470