BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2780064 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12380
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 6, 2012
    Report Date
    October 2, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT DURING A FOLLOW UP MANEUVERS WERE PERFORMED AND NOISE WAS NOT REPRODUCED. AN X-RAY TAKEN DID REVEAL A LEAD FRACTURE. THE DEVICE WAS INTERROGATED TO CHECK IF THERE WAS INTERFERENCE WITH THE MOTOR USED BY THE PATIENT, BUT NO NOISE EPISODES WERE RECORDED. THE PHYSICIAN SUSPECTED THAT THE NOISE COULD BE RELATED TO EXTERNAL MYOPOTENTIALS. AN INDUCTION TEST WILL BE PERFORMED AT THE NEXT FOLLOW UP. THE PHYSICIAN REQUESTED ADDITIONAL REVIEW BY TECHNICAL SERVICES TO ACCESS THE CAUSE/ORIGIN OF NOISE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT A FOLLOW UP TOOK PLACE. MANEUVERS WERE PREFORMED AND NOISE WAS REPRODUCED WHEN THE PATIENT PERFORMED DEEP BREATHING, WHILE THE IMPEDANCES DID NOT VARY. IT WAS RECONFIRMED THAT THE NOISE WAS MYOPOTENTIAL PROVOKED AND A LEAD FRACTURE WAS NO LONGER SUSPECTED. IT WAS NOTED THAT THIS LEAD WILL REMAIN IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP NOISE WAS OBSERVED ON THE LEFT VENTRICULAR LEAD. TECHNICAL ADVICE WAS REQUESTED. UPON REVIEW TECHNICAL SERVICES CONFIRMED THAT THE LEFT VENTRICULAR CHANNEL IS NOT PRESENT IN STORED ELECTROCARDIOGRAMS ON LATITUDE. HOWEVER, AS THE SHOCK ELECTROCARDIOGRAM IS FLAT, THIS IS INDICATIVE OF NO DEPOLARIZATION OCCURRING, NOT EVEN ON THE LEFT SIDE THUS ASYSTOLE FOR > 2 SECONDS. SUBSEQUENTLY, A FOLLOW UP TOOK PLACE AND VALSALVA MANEUVERS WERE PERFORMED WHICH DID NOT REPRODUCE NOISE. THE PATIENT REFERRED THAT HE CONNECTED A MOTOR SOMETIMES. THIS EXPLANATION WAS CONSISTENT WITH THE EPISODES OF NOISE RECORDED AT DIFFERENT TIMEFRAMES. THE PATIENT WAS REQUESTED TO CONNECT THE MOTOR EVERYDAY AT THE SAME TIME. WITHIN 15 DAYS AN INTERROGATION AND TRANSMISSION THROUGH LATITUDE WILL TAKE PLACE. THE PHYSICIAN WILL ANALYZE THE DATA THEN. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RIGHT VENTRICULAR LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| O H210| 4456| 4513| 4046| H125| 4543| 4469| 0185| 6744| 4549