BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211000 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07836
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 16, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE LEAD WAS RETURNED SEVERED 138 MM FROM THE TERMINAL PIN, TWO SEGMENTS WERE RETURNED, A TERMINAL END SEGMENT AND A TIP SEGMENT. THE TOTAL LENGTH WAS 640 MM. ALL FILARS APPEAR CUT. SET SCREW MARKS WERE NOTED, THREE ON THE IS-1 TERMINAL PIN, TWO ON THE DISTAL HIGH VOLTAGE TERMINAL END, AND TWO ON THE PROXIMAL HIGH VOLTAGE TERMINAL END. THE LEAD WAS RETURNED WITH THE EXTRACTING STYLET STUCK IN THE TIP SEGMENT OF THE LEAD. A SUTURE WAS TIED TIGHT AROUND THE LEAD BODY OF THE TIP SEGMENT FOR REMOVAL PURPOSES. SUTURE SLEEVE INDENTS WERE NOTED IN THE INSULATION 203 AND 210 MM FROM THE TERMINAL PIN. A CUT WAS NOTED IN THE INSULATION OF THE TIP SEGMENT OF THE LEAD. LASER DAMAGE WAS NOTED IN THE INSULATION OF THE TIP SEGMENT OF THE LEAD. THE TISSUE WAS NOTED ON THE LEAD BODY IN SEVERAL PLACES. SOME CALCIFICATION WAS NOTED AS WELL. BLOOD AND BODY FLUID WAS NOTED IN THE RATE SENSE LUMEN FROM THE TERMINAL PIN TO THE TIP AND IN THE HELIX HOUSING. THE HELIX WAS EXTENDED. THE LEAD PASSED CONTINUITY TESTING WITH MANIPULATION.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD REVISION WAS SCHEDULED DUE TO GREATER THAN 200 OHM IMPEDANCE MEASUREMENTS. DURING THE REVISION PROCEDURE THE LEAD WAS SUCCESSFULLY REPLACED. DURING FINAL TESTING, THE RIGHT ATRIAL (RA) LEAD WAS RECONNECTED TO THE DEVICE HOWEVER, NOISE AND GREATER THAN 2000 OHM PACING IMPEDANCE MEASUREMENTS WERE OBSERVED (THAT WERE NOT PRESENT PRIOR TO THE PROCEDURE). TESTING THROUGH THE PACING SYSTEM ANALYZER (PSA) REVEALED NORMAL VALUES WITH NO NOISE. THE DEVICE WAS EXPLANTED AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NORMAL MEASUREMENTS WERE NOTED WITH THE NEW DEVICE. THE PREVIOUS DEVICE AND RV LEAD WERE RETURNED FOR ANALYSIS TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310887 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R (B)(4)| 4136| N118| 0185| 0181| N164| 4518