BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN LV

    MDR report key: 3152884 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05715
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    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 WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT: C2TR01 IMPLANTABLE PULSE GENERATOR (IPG).(B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. THE LEFT VENTRICULAR CAPTURE THRESHOLDS HAD INCREASED STARTING AROUND DECEMBER 2012.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INCREASE IN THE LEFT VENTRICULAR (LV) THRESHOLD. THE DEVICE WAS REPROGRAMMED AND THE LEAD REMAINS IN USE WITH CLOSE MONITORING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255675 ATTAIN LV PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 2187-75

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention