BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 1921729 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12668
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 7, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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; (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE, HAVE ANALYZED THE DATA, AND HIGH RESISTANCE/IMPEDANCE WAS NOTED. THE DEVICE REPORTED 348 HIGH IMPEDANCE PACES RECORDED ON VENTRICULAR LEAD POST LEAD WARNING RECORDED ON (B)(6) 2010. EVALUATION SUMMARY (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA (B)(4) COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. (B)(4) IMPEDANCE - HIGH RESISTANCE/IMPEDANCE (B)(4), 348 HIGH IMPEDANCE PACES RECORDED ON VENTRICULAR LEAD POST LEAD WARNING RECORDED ON (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF POCKET STIMULATION, SYNCOPE AND PRESYNCOPAL EPISODES. SEVERAL VENTRICULAR HIGH RATE EPISODES, HIGH BIPOLAR LEAD IMPEDANCE AND RISING/HIGH THRESHOLDS WERE ALSO OBSERVED. IN ADDITION, OVERSENSING AND NOISE WERE OBSERVED. THE PATIENT HAD UNDERLYING CHRONIC ATRIAL FIBRILLATION AND VENTRICULAR PAUSES. MOST OF THE OBSERVATIONS SEEMED TO SUGGEST LEAD FRACTURE. THE LEAD WAS CAPPED AND 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 SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4024 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| O| R (B)(4) IMPLANTABLE PULSE GENERATOR