BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 3211679 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08616
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 29, 2013
    Report Date
    June 5, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE COMPLETE LEAD WAS RETURNED. THE LEAD PASSED ALL ELECTRICAL TESTING. ADDITIONAL TESTING WAS CONDUCTED WITH A 3105 PACING SYSTEM ANALYZER AND DILUTED PHOSPHATE BUFFERED SALINE. THE DISTAL END OF THE LEAD WAS PLACED IN THE SALINE SUCH THAT THE ELECTRODES WERE COMPLETELY SUBMERGED. A BIPOLAR PACED IMPEDANCE TEST WAS CONDUCTED AT 5 V IN VVI MODE. THE RESULT WAS A 558 OHM IMPEDANCE. A SIMILAR LEAD HAD AN IMPEDANCE OF 368 OHMS, AS THE LABORATORY DID NOT HAVE A 4549 LEAD ON HAND TO PERFORM THE TEST WITH). THIS TESTING FURTHER SUGGESTS THAT AN ANOMALY WITH THE LEAD ITSELF DID NOT CONTRIBUTE TO THE ALLEGATION OF HIGH OUT OF RANGE IMPEDANCE.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD SHOWED HIGH OUT OF RANGE PACING IMPEDANCES WHEN TESTING THE LEAD WITH THE PACING SYSTEM ANALYZER (PSA). THE PSA CABLES WERE CHANGED BUT THE IMPEDANCES REMAINED OUT OF RANGE. A LEAD ISSUE WAS SUSPECTED. THE LEAD WAS EXPLANTED AND ANOTHER LEAD WAS IMPLANTED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309268 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R