BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1072052 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03832
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    January 10, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWP
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 - THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. NO ANOMALIES FOUND WAS NOTED ON THE DATA DISC REVIEW.

    Additional Manufacturer Narrative · 1

    CORRECTED: PRODUCT EVENT SUMMARY: THE FULL LEAD IN SEGMENTS WAS RETURNED, ANALYZED, AND THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO ENVIRONMENTAL STRESS CRACKING WHILE IN VIVO. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ASKU

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 4076 IMPLANTABLE PACING LEAD| 7289 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD