BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3991581 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08033
    Event Type
    Injury
    Date Received
    August 8, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. CONCOMITANT MEDICAL PRODUCTS: 694765, LEAD, IMPLANTED: (B)(6) 2012; D314TRG, ICD, IMPLANTED: (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEFT VENTRICULAR (LV) LEAD DISLODGED, EXHIBITED HIGH THRESHOLDS AND EVENTUAL LOSS OF CAPTURE. THE LEAD WAS REMOVED AND WILL BE REPLACED WITH A DIFFERENT LEAD. THE ATRIAL LEAD EXHIBITED POSITIONAL HIGH THRESHOLDS WITH OCCASIONAL NO CAPTURE, AND SMALL P-WAVE UNDERSENSING. THE ATRIAL LEAD WAS REPOSITIONED TO THE LATERAL WALL AND REMAINS IN USE. FURTHER, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO UNEXPECTED LONGEVITY - EARLY BATTERY DEPLETION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470602 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R 407652, LEAD