BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4132205 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15321
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 13, 2011
    Report Date
    July 24, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, INTERROGATION REVEALED NO ISSUES. HOWEVER, A REVIEW OF THE STORED DATA NOTED THERE WAS A RIGHT VENTRICULAR VARIATION IN SHOCK IMPEDANCE. SHOCK IMPEDANCE MEASUREMENTS WERE FLUCTUATING, HOWEVER NO OUT OF RANGE MEASUREMENT WAS OBTAINED. MANIPULATION OF THE DEVICE/HEADER DID NOT REVEAL ANY VARIATION IN SHOCK IMPEDANCE. NO CHANGES WERE MADE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, THREE YEARS LATER, A DATA DISK WAS PROVIDED TO INTERNAL TECHNICAL SERVICES DUE TO A CHECK SHOCK LEAD DURING INTERROGATION. THE OVERALL TREND HAS VARIABILITY, HOWEVER OUT OF RANGE MEASUREMENTS WERE OBSERVED. IN ADDITION, WHEN THE PATIENT LIFTED HIS ARM UP AND ACROSS HIS BODY, SOME NOISE WAS OBSERVED ON THE SHOCK CHANNEL AND THE SHOCK IMPEDANCE WAS HIGH OUT OF RANGE. IT WAS THOUGHT THE NOISE WAS LIKELY MYOPOTENTIAL IN NATURE AND THE INCREASE IN THE SHOCK IMPEDANCE WAS LIKELY DUE TO AN INCREASE IN CHEST THORACIC IMPEDANCE POTENTIALLY. TS PROVIDED FEEDBACK THAT VARIABILITY WITH SHOCK IMPEDANCE CAN BE EXPECTED WITH A SINGLE COIL LEAD. NO VALUES SUGGESTED A PROBLEM WITH THE SYSTEM INTEGRITY. A DECISION WAS MADE TO FURTHER MONITOR THIS SYSTEM AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612082 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0161

    Patients

    Seq Age Sex Outcome Treatment
    1 F110| 0161| T167