BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 1990528 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02050
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. ANALYSIS RESULTS REVEALED THAT NO ANOMALIES WERE FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. ANALYSIS RESULTS REVEALED THAT NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS PRESENT ON ALL CONDUCTORS (NOT OBSTRUCTED). THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKS. (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS RESULTS REVEALED THAT NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS PRESENT ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED). THE DISTAL CONDUCTOR WAS DISTORTED AND THE OUTER INSULATION HAD ENVIRONMENTAL STRESS CRACKS. (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. ANALYSIS RESULTS REVEALED THAT NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS PRESENT ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED). THE DISTAL CONDUCTOR WAS DISTORTED, THE OUTER INSULATION HAD ENVIRONMENTAL STRESS CRACKS, AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "[T]HE PATIENT HAS SOME REJECTION AFFAIR AFTER THE DEVICE IMPLANTATION." THERE WAS SKIN BREAKDOWN NOTED AT THE DEVICE SITE. THE PHYSICIAN MADE NINE ATTEMPTS AT REPAIRING THE AFFECTED TISSUE; ALL WERE UNSUCCESSFUL. THE PATIENT HAD ALSO REPORTED EXPERIENCING PAIN. THE PACEMAKER AND LEFT VENTRICULAR LEAD WERE EXPLANTED IN THEIR ENTIRETY. THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS WERE PARTIALLY REMOVED AND CAPPED. THE PACEMAKER SYSTEM WAS REPLACED. 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 SENSE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4574 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R