BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2913285 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-17246
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 17, 2012
    Report Date
    June 13, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL INSPECTION NOTED THAT ONLY THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, AND THE INSULATION WAS TWISTED INDICATING TWIDDLERS SYNDROME. THERE WAS NOTED ELECTROCAUTERY DAMAGE ON THE LEAD. THE DAMAGE NOTED TO THE LEAD WAS DETERMINED TO BE AS A RESULT OF TWIDDLERS SYNDROME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING LOSS OF CAPTURE AND INCREASED THRESHOLDS. THE RIGHT ATRIAL (RA) LEAD WAS ALSO EXHIBITING ISSUES OF INCREASED IMPEDANCES. A CHEST X-RAY WAS TAKEN WHICH INDICATED THAT THE PATIENT WAS A TWIDDLER, AND TWIDDLED THE LEADS AROUND THE DEVICE. A REVISION PROCEDURE WAS DONE, WHICH SURGICALLY ABANDONED BOTH LEADS, AND TWO NEW LEADS WERE THEN IMPLANTED. POST IMPLANT, THERE WAS ONCE AGAIN LOSS OF CAPTURE ON THE NEWLY IMPLANTED RV LEAD. THEY PHYSICIAN THOUGHT THAT MAYBE THE DEVICE HEADER WAS DAMAGED FROM THE TWIDDLING, SO HE ELECTED TO EXPLANT AND REPLACE THE DEVICE. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19860 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L| R 4470| S606| 1298| 4469