BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911848 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16578
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 7, 2012
    Report Date
    January 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RETURN, THIS LEAD WAS THOROUGHLY ANALYZED. VISUAL INSPECTION CONFIRMED A COMPLETED LEAD; HOWEVER, SEVERED INTO TWO SEGMENTS (10.6 CM FROM THE TERMINAL PIN). AN EXTRACTING STYLET WAS STUCK INSIDE THE DISTAL LEAD SEGMENT. SETSCREW MARKS WERE OBSERVED ON THE TERMINAL PIN AND THE HELIX WAS IN A RETRACTED POSITION, PHYSICALLY INTACT, AND NO SIGNS OF DAMAGE OTHER THAN ENTWINED TISSUE. EXTENSIVE TESTING WAS THEN PERFORMED ON THE PROXIMAL SEGMENT, TO ASSESS ELECTRICAL INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS DEMONSTRATED CONTINUITY OF THE ELECTRICAL CIRCUITRY. SIMILAR TESTING ON THE DISTAL SEGMENT WAS UNABLE TO BE PERFORMED DUE TO THE STUCK EXTRACTING STYLET; HOWEVER, X-RAY OF THIS SEGMENT SHOWED NO LEAD FRACTURE POINTS. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD PRESENTED WITH INCREASED PACING THRESHOLD MEASUREMENTS AND REDUCED SENSING. LOSS OF CAPTURE WAS NOTED, BUT IT DID NOT RESULT IN INJURY TO THE PATIENT HAS THEY HAD AN UNDERLYING INTRINSIC RHYTHM. THE PACING AND SHOCK IMPEDANCE MEASUREMENTS HAD REMAINED STABLE. A CHEST X-RAY WAS TAKEN, AND THERE WAS NO EVIDENCE THAT THE LEAD HAD DISLODGED. THE PATIENT HAD NOT EXPERIENCED ANY COMPLAINTS DUE TO THE HIGH PACING THRESHOLDS; HOWEVER, THE PATIENT DID EXPERIENCE PAIN WHEN PACING AT MAXIMUM OUTPUTS. THE PHYSICIAN SUSPECTED A LEAD PERFORATION. A LEAD REVISION WAS PERFORMED AND THIS RV LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. THE PERFORATION WAS UNABLE TO BE CONFIRMED DURING THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD WILL BE RETURNED FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18993 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R