BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 1072988 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03717
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    October 2, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWP
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO ANOMALIES FOUND; FULL LEAD RETURNED FOR ANALYSIS. NO ANOMALIES FOUND; DISTAL SEGMENT RETURNED FOR ANALYSIS. IT WAS REPORTED THE PATIENT FELL ON THEIR LEFT SHOULDER AND SHORTLY THERE AFTER HEART RATE WAS NOTED AS 40 BPM. IT WAS FOUND THAT THE LV 4193 LEAD HAD NO CAPTURE, THE RV 4068 LEAD HAD RISEN IN CAPTURE THRESHOLD AND THE DEVICE EXHIBITED SENSING DIFFICULTIES. THE ENTIRE SYSTEM WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. ELECTRICAL TESTS PERFORMED; MECHANICAL TESTS PERFORMED. VISUAL EXAMINATION: DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CAPTURE, FAILURE TO.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL ON THEIR LEFT SHOULDER AND SHORTLY THERE AFTER HEART RATE WAS NOTED AS 40 BPM. IT WAS FOUND THAT THE LV 4193 LEAD HAD NO CAPTURE, THE RV 4068 LEAD HAD RISEN IN CAPTURE THRESHOLD AND THE DEVICE EXHIBITED SENSING DIFFICULTIES. THE ENTIRE SYSTEM WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW IMPLANTABLE PACING LEAD LWP MEDTRONIC PUERTO RICO, INC. 4193 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention