BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1881338 · Received October 25, 2010

    Report

    Report Number
    2124215-2010-17898
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 13, 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

    - -

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS REPLACED. IT IS UNKNOWN AT THIS TIME WHETHER THE LEAD WILL BE RETURNED FOR ANALYSIS, THEREFORE BOSTON SCIENTIFIC CRM CANNOT CONFIRM NOR DENY THIS REPORTED CLINICAL ALLEGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, INTERROGATION OF THIS RIGHT VENTRICULAR LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE REVEALED THE PATIENT HAD RECEIVED AN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) SHOCK DUE TO OVERSENSING NOISE. WHEN THE PHYSICIAN MOVED THE ARM OF THE PATIENT THE NOISE WAS REPRODUCED. POCKET MANIPULATION DID NOT REVEAL OVERSENSING. THE PHYSICIAN DID NOT THINK THERE WAS A CONNECTION ISSUE. IT WAS THOUGHT THERE MAY BE A RIGHT VENTRICULAR LEAD ISSUE AS THE IMPEDANCE MEASUREMENTS WERE UNSTABLE. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED AND REVIEWED THE DATA. NOISE WAS OVERSENSED GREATER THAN TWO SECONDS, HOWEVER THERE WAS NO PACING INHIBITION AS THE PATIENT HAS AN UNDERLYING INTRINSIC RHYTHM. APPROPRIATE RIGHT VENTRICULAR PACING WAS NOTED. IT WAS SUGGESTED TO FURTHER DETERMINE WHETHER THIS LEAD IS DAMAGED, HOWEVER THERE IS NO EVIDENCE OF SHOCK IMPEDANCE PERFORMANCE. IT WAS NOT THOUGHT THE ISSUE WAS DUE TO A LEAD/DEVICE CONNECTION ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED: A FURTHER EPISODE OF OVERSENSING OCCURRED WITHOUT ADVERSE PATIENT EFFECTS. A REVISION PROCEDURE WAS PERFORMED. AN XRAY REVEALED THE VEIN WAS BLOCKED. THIS LEAD WAS SUCCESSFULLY REPLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED; THE LEAD WAS SURGICALLY ABANDONED. IT COULD NOT BE DETERMINED WHETHER THE LEAD WAS FRACTURED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention