BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 1071981 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03797
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    May 27, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. 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. THE DEVICE IS INCLUDED IN THE FIELD ADVISORY FOR THIS MODEL AND TESTED OUT OF SPECIFICATION CONSISTENT WITH THE ADVISORY. EVALUATION SUMMARY PRELIMINARY TESTING CONFIRMED THE REPORTED NO OUTPUT AND NO TELEMETRY. FURTHER ANALYSIS DETERMINED THIS WAS THE RESULT OF LIFTED HYBRID BOND WIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE PATIENT'S PREVIOUS DEVICE INTERROGATION, THE DEVICE INDICATED A REMAINING LONGEVITY OF 2-4 YEARS. FIVE MONTHS LATER, DURING ANOTHER ROUTINE DEVICE INTERROGATION, THE PATIENT PRESENTED WITH NO MAGNET RESPONSE, NO OUTPUT AND NO TELEMETRY POSSIBLE. FURTHER, THE PATIENT REPORTED SYNCOPAL EPISODES IN RECENT MONTHS. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT ONE DAY POST-DEVICE CHANGE, THE LEAD WAS CAPPED AND REPLACED DUE TO UNACCEPTABLE THRESHOLDS. NO FURTHER PATIENT COMPLICATIONS WERE 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. 4024 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 4024 IMPLANTABLE PACING LEAD