BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2913360 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-17251
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 17, 2012
    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

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    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 OBSERVATIONS CONFIRMED THAT THE COMPLETE LEAD WAS RETURNED AND THERE WAS DRIED BODY FLUID NOTED THROUGHOUT THE ENTIRE LEAD LUMEN. THERE WERE CUTS IN THE INSULATION AT 188 - 190, 250 - 255. 293 AND 296 MM FROM THE TERMINAL PIN. THERE WAS NOTHING VISUALLY WRONG WITH THE LEAD THAT WOULD CAUSE A DISLODGEMENT.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION BECAME AVAILABLE THAT THIS LEAD HAD DISLODGED, AND WAS EXPLANTED AND REPLACED AS A RESULT. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    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

    ADDITIONAL INFORMATION BECAME AVAILABLE THAT THIS LEAD HAS BEEN EXHIBITING HIGHER THAN DESIRABLE THRESHOLDS AND THE HEALTH CARE PROFESSIONAL (HCP) WAS CONCERNED FOR THE IMPACT IT MIGHT HAVE ON THE DEVICE LONGEVITY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED FOR A CALCULATION AND STATED THAT AT CURRENT SETTINGS THERE WAS APPROXIMATELY 1.4 YEARS REMAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20758 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L| R 4135| 4469| 1298| 4470| S606| 4456