BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3041096 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-05381
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    December 25, 2012
    Report Date
    July 25, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    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.

    Additional Manufacturer Narrative · 1

    ONCE ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT WAS DETECTED ON THIS RIGHT VENTRICULAR (RV) LEAD. IT WAS ALSO DISCOVERED THERE WERE SEVERAL RECORDED EPISODES FOR OVERSENSING OF NOISE ON THE VENTRICULAR CHANNEL. ONE EPISODE LED TO INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP). ALL THE EPISODES WERE RECORDED ON ONE DAY IN DECEMBER IN THE MORNING. ADDITIONAL INFORMATION WAS RECEIVED THAT NOISE HAS BEEN OBSERVED ON THIS RV LEAD IN THE MORNING EACH DAY. THE PACING IMPEDANCE MEASUREMENTS HAVE REMAINED IN NORMAL RANGE. IT IS SUSPECTED THAT THE HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT WAS DUE TO A DAILY MEASUREMENT BEING TAKEN DURING ONE OF THE EPISODES OF NOISE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PATIENT WILL CONTINUE TO BE MONITORED. THE RV LEAD REMAINS IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT NOISE WAS STILL BEING DETECTED ON THIS RV LEAD. A CHEST X-RAY WAS PERFORMED AND A FRACTURE WAS NOTED CLOSE TO THE SUTURE SLEEVE TIE DOWN. THE PATIENT HAD A FALL BACK IN (B)(6) WHICH COINCIDES WITH WHEN THE PACING IMPEDANCE MEASUREMENTS HAD INCREASED FROM 650 TO ABOVE 3,000 OHMS. THE PACING THRESHOLDS HAD ALSO INCREASED AT THE SAME TIME. A NEW RATE/SENSE LEAD WILL BE IMPLANTED IN THE FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT A REVISION WAS PERFORMED AND THIS LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143206 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R T177| 0184