BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1873818 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17346
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 17, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS RIGHT VENTRICULAR LEAD DISPLAYED NOISE CAUSING OVERSENSING AND PACING INHIBITION. SIMILAR SYMPTOMS WERE REVEALED WITH THE PREVIOUS DEVICE. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED REGARDING WHETHER THERE COULD BE A LEAD ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS SUBSEQUENTLY RECEIVED THAT THE NOISE AND OVERSENSING CONTINUED. THIS RESULTED IN GREATER THAN TWO SECONDS OF ASYSTOLE. THE NOISE IS NOW ALSO PRESENT ON THE RIGHT ATRIAL (RA) LEAD. VARIATIONS IN IMPEDANCE MEASUREMENTS ON THE RA AND RIGHT VENTRICULAR (RV) LEADS WERE NOTED; HOWEVER, THEY REMAIN WITHIN THE NORMAL RANGE. ADDITIONALLY, THERE WERE LOW AMPLITUDE MEASUREMENTS ON THE RV LEAD. THE DEVICE WAS EXPLANTED, BUT NO INFORMATION WAS RECEIVED REGARDING THE LEADS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. A REVIEW OF THE INFORMATION BY TECHNICAL SERVICES CONFIRMED NOISE CAUSING OVERSENSING AND RECOMMENDED FURTHER LEAD INTERROGATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O