BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3212657 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10416
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    February 1, 2013
    Report Date
    May 29, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ON PREVIOUS EVALUATIONS THERE WERE NOISE AND OVERSENSING RESULTING IN PACING INHIBITION ON THIS RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS PACEMAKER DEPENDENT, BUT NOT ASYSTOLE GREATER THAN TWO SECONDS WAS NOTED. PROGRAMMING CHANGES WERE MADE IN AN ATTEMPT TO MITIGATE THE ISSUE. RECENTLY, THE PATIENT HAD PRESYNCOPE AND DIZZINESS. THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE A FALL WHICH RESULTED IN A BROKEN ANKLE. DEVICE INTERROGATION REVEALED INTERMITTENT LOSS OF CAPTURE ON THE RV LEAD, AND THE DEVICE WAS REPROGRAMMED TO DOO PACING AT 90 BPM. SURGICAL INTERVENTION WAS PERFORMED AND IT WAS SUSPECTED THAT THE LEAD'S INSULATION WAS DAMAGED AS A KINK WAS OBSERVED BEYOND WHERE IT WAS INSERTED INTO THE SUBCLAVIAN VEIN; HOWEVER, THE INSULATION DAMAGE WAS NOT VISUALIZED. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. ALSO, THE PHYSICIAN ELECTED TO CHANGE-OUT THE PATIENT'S PACEMAKER AS IT WAS NEARING ELECTIVE REPLACEMENT INDICATOR (ERI), AND THE PHYSICIAN DID NOT WANT TO REOPEN THE POCKET WITHIN A YEAR TO REPLACE THE DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312221 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R 1291| 4470| 4469