BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 2811615 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16871
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOWUP SESSION UNACCEPTABLE THRESHOLDS WERE NOTED, RESULTING IN EXIT BLOCK. THE LEAD WAS REPOSITIONED; HOWEVER SEVERAL OF MONTHS LATER THE THRESHOLDS WERE WORSE AGAIN SO THE LEAD WAS REPLACED. DURING THE REVISION THE PATIENT EXPERIENCED A PNEUMOTHORAX DUE TO PUNCTURE OF THE THE SUBCLAVIAN VEIN AND PLEURAL DRAINAGE WAS PERFORMED. THREE DAYS LATER THE THRESHOLD WAS ONCE AGAIN UNACCEPTABLE. DURING THE REVISION PROCEDURE, THE LEAD THRESHOLD MEASUREMENTS WERE ACCEPTABLE ON THE ANALYZER SO THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SENSE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4074

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R