BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 1802983 · Received August 17, 2010

    Report

    Report Number
    2649622-2010-08749
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    June 15, 2010
    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
    GA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO SYNCOPAL SPELLS RESULTING IN HEAD INJURY; APPARENT SUBCLAVIAN CRUSH FRACTURE OF LEAD. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER INFORMATION RECEIVED INDICATES THE "PACEMAKER" "STOPPED WORKING" [LATER FOUND TO BE THE LEAD] CAUSING THE PATIENT TO PASS OUT THREE TIMES, ONE OF WHICH RESULTED IN A LACERATION TO THE HIS HEAD WHICH RESULTED IN A LOSS OF "A LOT" OF BLOOD, REQUIRED STITCHES, AND REMAINED PAINFUL. IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE FINE AND REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE LEAD WAS FOUND TO HAVE HIGH THRESHOLD, NO CAPTURE, HIGH IMPEDANCE DUE TO AN APPARENT SUBCLAVIAN CRUSH FRACTURE OF THE LEAD. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO SYCOPAL SPELLS RESULTING IN HEAD INJURY; APPARENT SUBCLAVIAN CRUSH FRACTURE OF LEAD. THE LEAD WAS CAPPED 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 SENSE ASKU DTB MEDTRONIC PUERTO RICO, INC. 4074 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 5568 IMPLANTABLE PACING LEAD| 5568 IMPLANTABLE PACING LEAD| 5568 IMPLANTABLE PACING LEAD