BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2052621 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04595
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 24, 2011
    Report Date
    November 9, 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

    PER THE BOSTON SCIENTIFIC LOCAL AREA SALES REPRESENTATIVE, THERE WAS NEVER A LEAD DISLODGMENT, ONLY SURGICAL REVISION TO OPTIMIZE THERAPY DUE TO CHANGE IN PATIENT CONDITION (INCREASE IN THRESHOLDS). THIS LEAD WAS REMOVED FROM SERVICE BECAUSE IT COULD NOT BE OPTIMALLY PLACED, AND FOR NO OTHER REASON. THIS LEAD WAS REPLACED WITH A DIFFERENT MODEL OF LEAD. NO OTHER LEADS WERE ATTEMPTED OR IN SERVICE RELATED TO THIS EVENTED INFORMATION.

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN OBSERVED THE NEW LEAD PLACEMENT UNDER FLUOROSCOPY, THAT THE LEAD APPEARED TO BE IN THE SAME PLACE IT WAS BEFORE; THEREFORE, EXHIBITED DISLODGMENT. THIS RV LEAD WAS SURGICALLY REVISED AND WAS IN SERVICE FOR A SHORT TIME. THEN A SECONDARY PROCEDURE WAS DONE TO REMOVE THIS RV LEAD FROM SERVICE, AS PACE THRESHOLDS WERE INCREASING. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, INVESTIGATION IS CONSIDERED COMPLETE. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD DID EXHIBIT INTERMITTENT LOSS OF CAPTURE (LOC), WITH OKAY SENSING OUTCOMES AND HIGH PACING THRESHOLD OF 3.0 AT 1.5 AFTER APPROXIMATELY FIVE YEARS OF IMPLANT. THE PHYSICIAN ELECTED TO SURGICALLY REVISE THE LEAD, AT WHICH POINT SENSING WAS NOT SUFFICIENT. THE LOCAL AREA SALES REPRESENTATIVE CONFIRMED THAT THERE WERE NO REPORTED ADVERSE PATIENT SYMPTOMS, SUCH AS ASYSTOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention E110| 4469| 0184