BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2161610 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07805
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE OF THE UNDERSENSING THAT IMPACTED CRITICAL THERAPY, THIS LEAD WAS REMOVED FROM SERVICE VIA SURGICAL INTERVENTION AS A RESULT. THE ASSOCIATED MEDICAL DEVICE WAS NOT REMOVED FROM SERVICE, ALTHOUGH INITIALLY THE PHYSICIAN DISCUSSED ANTICIPATED LONGEVITY AND CONSIDERED REMOVING THE DEVICE AT THE SAME TIME AS THIS DISLODGED LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD HAD BECOME DISLODGED, AND THE PATIENT EXPERIENCED DIZZINESS, NEAR SYNCOPE, AND PRESENTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 4517| 4047| 5076| 0180| T165| H220