BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 2811639 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17124
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015/S012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT PERFORMANCE SUMMARY: PRODUCT PERFORMANCE INFORMATION WAS COLLECTED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT IS A PARTICIPANT IN THE CLINICALSERVICE PROJECT STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT IS A PARTICIPANT IN THE (B)(4) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 4194

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R