BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3615648 · Received February 8, 2014

    Report

    Report Number
    2649622-2014-00830
    Event Type
    Injury
    Date Received
    February 8, 2014
    Report Date
    December 16, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    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 PRODUCTS: 5069 X 2 IMPLANTABLE PACING LEAD (B)(6) 1994; 8042B IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 2010; D224TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (B)(6) 2009; 5866 ADAPTOR (B)(6) 1994; 6721L IMPLANTABLE TACHY LEAD (B)(6) 1994; 6721L IMPLANTABLE TACHY LEAD (B)(6) 1994; 430 COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 1993; 432 COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 1993. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXPERIENCED A BREACH IN INSULATION AND THE FILAR WAS VISIBLE. THE LV LEAD WAS CAPPED 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
    84880 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Hospitalization| R