BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1851745 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14053
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 7, 2010
    Report Date
    September 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTAL SECTION OF THE LEAD WAS RETURNED WITH THE EXTRACTING STYLET STUCK IN THE TIP OF THE LEAD. MULTIPLE CUTS WERE NOTED IN THE INSULATION. THE CONDUCTOR COILS WERE EXTREMELY STRETCHED AND DEFORMED, LIKELY DUE TO THE EXTRACTION PROCEDURE. THE OUTER INSULATION ON THE RATE/SENSE PORTION OF THE LEAD WAS BUNCHED, AND THE GORE COVERING WAS SEPARATED FROM THE MEDICAL ADHESIVE AT THE PROXIMAL EDGE OF THE PROXIMAL SHOCKING COIL. A SLIGHT STRETCHING OF THE PROXIMAL END OF THIS SHOCKING COIL WAS ALSO NOTED. ELECTRICAL TESTING WAS PERFORMED AND THE LEAD SEGMENT WAS FOUND TO BE ELECTRICALLY CONTINUOUS. NO FURTHER TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE LEAD SEGMENT. THE CLINICAL OBSERVATIONS OF DISLODGEMENT, HIGH THRESHOLDS, AND LOW R-WAVES COULD NOT BE CONFIRMED IN LABORATORY TESTING.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IN SERVICE WITHOUT COMPLICATION. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE CLINICIAN REPORTED THAT THE CLINIC AND THE PHYSICIANS WERE ALL AWARE OF THE LOW INTRINSIC AMPLITUDE ISSUE. DUE TO THE PATIENT'S ONGOING RECOVERY FROM THE RECENT SURGERY, THE PLAN WAS TO HOLD OFF ON ANY FURTHER INTERVENTION AT THIS TIME. THE ISSUE WILL CONTINUE TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT WAS SCHEDULED FOR A LEAD REPLACEMENT. THE FIELD REPRESENTATIVE REPORTED THAT THE RV LEAD DID NOT APPEAR TO BE DISLODGED ON X-RAY, BUT THE PACING THRESHOLDS WERE HIGH AND THE R-WAVES WERE LOW, SO THE LEAD WAS EXPLANTED AND WAS REPLACED WITH A COMPETITIVE DEFIBRILLATION LEAD. THE LEAD WAS DAMAGED DURING LASER EXTRACTION, BUT THE HOSPITAL INTENDED TO RETURNED THE LEAD TO BOSTON SCIENTIFIC. AS OF TODAY, THE LEAD HAS NOT BEEN RECEIVED. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED LEAD WAS RETURNED AND IS UNDERGOING LABORATORY ANALYSIS. THIS REPORT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS TRANSVENOUS DEFIBRILLATION LEAD UNDERWENT OPEN HEART SURGERY. IT WAS THEN NOTED THAT THE LEAD HAD DISLODGED DUE TO THE SURGERY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED NEW INFORMATION THAT A YELLOW ALERT WAS ISSUED DUE TO LOW RIGHT VENTRICULAR (RV) INTRINSIC AMPLITUDE MEASUREMENTS. IT WAS ALSO NOTED THAT PACING THRESHOLDS HAD INCREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention 0184| 4470| E110