BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211247 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08386
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 9, 2013
    Report Date
    June 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE TESTS WERE COMPLETED TO ASSESS THE LEAD¿S ELECTRICAL PERFORMANCE; MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE LEAD BEING DIFFICULT TO MANIPULATE DURING REPOSITIONING OR TO THE CLINICAL OBSERVATION OF DISLODGEMENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE AT MAXIMUM PACING OUTPUTS. AN X-RAY WAS PERFORMED, WHICH CONFIRMED THE LEAD WAS DISLODGED. A LEAD REVISION WAS PERFORMED; AN ATTEMPT WAS MADE TO REPOSITION THIS LEAD, BUT THE PHYSICIAN FOUND THE LEAD DIFFICULT TO MANIPULATE. THE LEAD WAS EXPLANTED AND REPLACED WITH ANOTHER LEAD OF THE SAME MODEL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310648 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R