BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1950594 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22763
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 11, 2010
    Report Date
    November 22, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE SHOCK PORTION OF THIS LEAD REMAINS IN SERVICE. 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 THIS TRANSVENOUS DEFIBRILLATION LEAD EXHIBITED A HISTORY OF NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL. IT WAS NOTED THAT THE NOISE ON THE RV CHANNEL RESULTED IN DIVERTED EPISODES, INAPPROPRIATE SHOCKS AND PAUSES IN PACING. THESE EPISODES OF NOISE WERE NOTED TO BE OCCURRING AT NIGHT. THE PATIENT WAS NOTED TO HAVE AN UNDERLYING VENTRICULAR ESCAPE RHYTHM OF APPROXIMATELY 30 BEATS PER MINUTE. IT WAS ALSO NOTED THAT THE PATIENT HAD BEEN LOST TO FOLLOW-UP FOR APPROXIMATELY TWO YEARS. ALL OTHER LEAD MEASUREMENTS WERE NOTED TO BE OKAY, AND THE NOISE COULD NOT BE RECREATED. ADDITIONAL INFORMATION WAS LATER RECEIVED THAT THE PATIENT WAS IN THE HOSPITAL FOR A POSSIBLE LEAD REVISION. THE REMAINING LONGEVITY WAS QUESTIONED FOR THE DEVICE, AS THE PHYSICIAN WAS CONSIDERING REPLACING THE DEVICE DURING THE LEAD REVISION. TECHNICAL SERVICES (TS) DISCUSSED IT WAS PHYSICIAN DISCRETION TO REPLACE THE DEVICE. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT A REVISION PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, THE DECISION WAS MADE TO SURGICALLY ABANDON THE RATE/SENSE PORTION OF THIS DEFIBRILLATION LEAD, AND IMPLANT A NEW RATE/SENSE LEAD IN THE RV. THE DEVICE WAS ALSO ELECTIVELY EXPLANTED DURING THE PROCEDURE. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    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 65 YR Required Intervention 0185| 4470| H210| 4555