BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780003 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13457
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 6, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEADS REMAIN IMPLANTED AND SURGICALLY ABANDONED AT THIS TIME. 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 THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD WERE CAPPED. THE PATIENT WAS BROUGHT IN FOR EVALUATION, NOISE WITH OVERSENSING WAS OBSERVED, BUT DID NOT INHIBIT PACING BECAUSE PATIENT'S OWN RHYTHM WAS IN 80'S BEATS PER MINUTE (BPM). OVERSENSING HOWEVER DID ON THE RV LEAD DID RESULT IN THE INAPPROPRIATE DELIVERY OF ANTI-TACHYCARDIA PACING (ATP). LOW OUT OF RANGE IMPEDANCE MEASUREMENTS WERE ALSO OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. DURING THE EVALUATION A CHEST X-RAY WAS PERFORMED AND BOTH LEADS APPEARED TO BE STILL IN PLACE, HOWEVER THERE WAS NO BOOT ON EITHER OF THE LEADS AND VISUALLY COULD SEE A BALL EXTENDING FROM THE POCKET. A LEAD REVISION WAS PERFORMED AND CONFIRMED BOTH LEADS WERE FOUND COILED CONCLUDING PATIENT HAS TWIDDLER'S SYNDROME. DURING THE REVISION THE PHYSICIAN WAS UNABLE TO OBTAIN VEINOUS ACCESS, PROCEDURE WAS ABANDONED AND BOTH LEADS WERE CAPPED. THE PATIENT WILL BE TRANSFERRED TO ANOTHER FACILITY FOR POTENTIAL LEAD EXTRACTION. THERE WERE NO ADVERSE PATIENT EFFECTS OR PATIENT SYMPTOMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 4470| 0185| E110