BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 1072627 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03454
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    April 1, 2008
    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
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. 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: NO ANOMALIES FOUND; FULL LEAD IN SEGMENTS RETURNED AND ANALYZED. IT WAS REPORTED THE LEAD WAS EXPLANTED AND REPLACED, DUE TO HIGH IMPEDANCE (GREATER THAN 9999 OHMS). NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S STATUS WAS REPORTED AS 'OK' FOLLOWING THE REPLACEMENT PROCEDURE. 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. IMPEDANCE, HIGH.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS EXPLANTED AND REPLACED, DUE TO HIGH IMPEDANCE (GREATER THAN 9999 OHMS). NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S STATUS WAS REPORTED AS 'OK' FOLLOWING THE REPLACEMENT PROCEDURE.

    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 Other| R