BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE VDD-2

    MDR report key: 1061581 · Received June 12, 2008

    Report

    Report Number
    2649622-2008-03251
    Event Type
    Injury
    Date Received
    June 12, 2008
    Date of Event
    June 11, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: NO ANOMALIES FOUND; PROXIMAL SEGMENT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    A CALL WAS RECEIVED THROUGH TECHNICAL SERVICES REPORTING SYNCOPAL EPISODE AND HIGH IMPEDANCE NOTED. LEAD FRACTURE CONSIDERED. THE LEAD WAS REPLACED AND RETURNED, WITH A REPORT OF UNDERSENSING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED INDICATES PT FELL AFTER SYNCOPAL EPISODE RESULTING IN MINOR ABRASION TO RIGHT PERIORBITAL AREA. HR WAS 30-40 BPM WHEN EMT ARRIVED TO TRANSPORT TO HOSPITAL. PT ALERT. DEVICE INTERROGATION SHOWED NOISE AND BIPOLAR IMPED 1000 OHMS/UNIPOLAR WAS 500 OHMS BOTH SUGGESTING MICROFRACTURE OF LEAD. CHEST X-RAY SHOWED LEAD STRETCHED BUT NO FRACTURE. LEAD 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 VDD-2 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5038S ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention KVDD901 IMPLANTABLE PULSE GENERATOR