BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 3993433 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09317
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. CONCOMITANT PRODUCT: D314TRM ICD, IMPLANTED: (B)(6) 2012; 6947M62 LEAD, IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INCREASE IN THRESHOLDS WAS OBSERVED ON THE PATIENT'S LEFT VENTRICULAR (LV) LEAD. THE LV LEAD REMAINS IN USE. THIS PATIENT IS A PARTICIPANT IN A PRODUCT SURVEILLANCE REGISTRY CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469368 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR 407652 LEAD