BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2203443 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11697
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S10
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 AND ANALYZED. NO ANOMALIES WERE FOUND. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS FOUND ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED). THE OUTER INSULATION EXHIBITED COSMETIC ENVIRONMENTAL STRESS CRACKING AND DEPRESSION, AND A COSMETIC CUT. APPARENT EXPLANT DAMAGE WAS NOTED. A VISUAL ANALYSIS WAS ONLY PERFORMED ON THE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTROCARDIOGRAM SHOWED A LOSS OF CAPTURE UP TO 12 SECONDS, WHICH COULD NOT BE PROVOKED MANUALLY. THE PHYSICIAN COULD NOT DETERMINE IF THE PROBLEM WAS WITH THE DEVICE OR THE LEAD. THE DEVICE AND LEAD WERE BOTH EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4023 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R