BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3971355 · Received July 31, 2014

    Report

    Report Number
    2124215-2014-13691
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    June 18, 2014
    Report Date
    May 12, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    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

    ADDITIONAL INFORMATION WAS RECEIVED AND INDICATED THAT HIGH PACING LEAD IMPEDANCE CONTINUES TO BE INTERMITTENTLY OUT OF RANGE. AT THIS TIME THERE IS NO EVIDENCE THAT INTERVENTION HAS BEEN PERFORMED TO RESOLVE THIS ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING LEAD IMPEDANCE (PLI) MEASUREMENTS FROM 1800 OHMS TO 1900 OHMS. DURING NORMAL DEVICE CHANGE OUT, THIS LEAD HAD PLI AT 2050 OHMS WITH THE PACING SYSTEM ANALYZER (PSA) AND HAD GREATER THAN 2000 OHMS WITH THE NEW DEVICE. THE PHYSICIAN DID NOT WANT TO MAKE ANY CHANGES. ALL OTHER MEASUREMENTS WERE WITHIN RANGE. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT OF RANGE SHOCK AND PACE IMPEDANCES MEASUREMENTS. SURGICAL INTERVENTION WAS PERFORMED TO ABANDON AND REPLACE THE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446676 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R 4470| E163| T180