BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3160269 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07965
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  IMPLANTED: (B)(6) 2009, 6947 IMPLANTABLE TACHY LEAD IMPLANTED: (B)(6) 2009, 5076 IMPLANTABLE PACING LEAD IMPLANTED: (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS EXPERIENCING HIGH THRESHOLDS AND NO CAPTURE. THE LEAD WAS TO BE EXPLANTED AND REPLACED. DURING THE REPLACEMENT PROCEDURE, AFTER THE DEVICE WAS REMOVED, IT WAS NOTED THAT BOTH THE LV AND RIGHT VENTRICULAR (RV) LEADS HAD AN APPARENT FRACTURE, AND THAT THE LEADS WERE ALL "JUMBLED UP IN THE POCKET." THE LV AND RV LEADS WERE THEN CAPPED, AND WERE LATER EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260667 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R