BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK DSP

    MDR report key: 2280346 · Received October 6, 2011

    Report

    Report Number
    2124215-2011-16280
    Event Type
    Injury
    Date Received
    October 6, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    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

    MOST RECENTLY, THIS RV LEAD WAS REMOVED FROM SERVICE FOR THE ISSUE AND THE ASSOCIATED ICD WAS REMOVED FOR NORMAL BATTERY DEPLETION. THE RV LEAD WAS SURGICALLY ABANDONED. NO FURTHER INFORMATION IS EXPECTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD DID EXHIBIT OUT-OF-RANGE PACE IMPEDANCE GREATER THAN 2,000 OHMS IN ASSOCIATION WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AS WELL AS NOISE OVERSENSING. THE NOISE WAS ABLE TO BE REPRODUCED THROUGH ISOMETRIC POCKET MANIPULATIONS AND WHEN THE PATIENT RAISED THEIR ARM ABOVE SHOULDER HEIGHT. THE PHYSICIAN PLANNED TO MONITOR THE ISSUE CLOSELY AND NO SURGICAL INTERVENTION IS PLANNED AT THIS TIME. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECT, SUCH AS ASYSTOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK DSP IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 1821| E110| 4470| 0125| 4244| 1861