BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3905386 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-13242
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    December 2, 2013
    Report Date
    November 20, 2018
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT HAD DISCUSSED THAT LEAVING A PORTION OF GUIDE WIRE WITHIN THE LEAD WAS OFF-LABEL USE AND THE EFFECT OF HAVING THE WIRE IN THE LEAD COULD NOT BE KNOWN. BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION. AN ALERT WAS NOTED IN THE PATIENT'S REMOTE MONITORING SYSTEM FOR A HIGH, OUT-OF-RANGE LV PACING IMPEDANCE MEASUREMENT OF GREATER THAN 2,000 OHMS. THE PATIENT WAS SEEN AT THE HOSPITAL THE FOLLOWING DAY. LEAD TESTING FOUND IMPEDANCE MEASUREMENTS BETWEEN 700-1,000 OHMS. AN X-RAY WAS PERFORMED, BUT NO LEAD ISSUES WERE OBSERVED. IT WAS NOTED THAT WHEN THE PATIENT CHANGED POSITIONS, THE LV PACING IMPEDANCE MEASUREMENT WAS GREATER THAN 2,000 OHMS. NOISE WAS REPRODUCED DURING POCKET MANIPULATION. A LEAD FRACTURE WAS SUSPECTED. IT WAS NOT KNOWN WHETHER THE RETAINED GUIDE WIRE HAD CAUSED THE NOISE, IMPEDANCE ISSUE, OR POTENTIAL FRACTURE. THE PHYSICIAN PLANNED TO CONTINUE MONITORING THE LEAD.

    Additional Manufacturer Narrative · 1

    (B)(4). BOSTON SCIENTIFIC RECEIVED NEW INFORMATION THAT THIS LV LEAD CONTINUED TO EXHIBIT PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 2,000 OHMS. NOISE WAS OBSERVED ON THE LEAD, AND THE LV PACING THRESHOLD MEASUREMENTS HAD ALSO INCREASED, TO MORE THAN 6.5V IN BOTH UNIPOLAR AND BIPOLAR CONFIGURATIONS. AT A HIGHER PACING OUTPUT, THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. THEREFORE, THE DEVICE WAS REPROGRAMMED TO PACE IN THE RV ONLY. THE PHYSICIAN WILL MONITOR THE PATIENT¿S HEART FAILURE PROGRESS AND DETERMINE AT A LATER DATE IF THE LV LEAD WILL BE REPLACED. THE LEAD REMAINS IMPLANTED BUT NOT IN USE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. RESISTANCE TESTING FOUND THE LEAD WAS NOT ELECTRICALLY CONTINUOUS AND AN X-RAY OF THE LEAD VERIFIED IT WAS FRACTURED AT 43.7 CM, 46.9 CM, AND 65.5 CM FROM THE TERMINAL PIN. THE X-RAY ALSO SHOWED THE PORTION OF GUIDE WIRE RETAINED WITHIN THE LEAD WAS LOCATED IN THE REGION 40-76 CM FROM THE TERMINAL PIN. THE WIRE APPEARED TO HAVE SEVERAL BENDS IN IT AND IT WAS AT THE LOCATION OF EACH BEND THAT THE LEAD HAD BECOME FRACTURED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AT A ROUTINE FOLLOW-UP, NOISE WAS OBSERVED ON THE LEFT VENTRICULAR (LV) LEAD. THE NOISE WAS OVERSENSED, RESULTING IN INHIBITED LV PACING. ALL LEAD MEASUREMENTS WERE WITHIN NORMAL RANGE. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN HAD INTENTIONALLY RETAINED A PORTION OF THE GUIDE WIRE IN THE LV LEAD, TO MAINTAIN POSITION. AN X-RAY SHOWED THAT THE LEAD HAD NOT MOVED. THE PHYSICIAN DID NOT BELIEVE THE GUIDE WIRE TO BE THE CAUSE OF THE NOISE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION. THIS LV LEAD WAS EXPLANTED DURING A DEVICE REPLACEMENT PROCEDURE. NO NEW LEAD WAS IMPLANTED AS THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS REPLACED WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382321 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 4542| 4554