BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3992960 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09573
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 6947-65, LEAD, IMPLANTED: (B)(6) 2002; 5032-58, LEAD, IMPLANTED: (B)(6) 1998. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS CAPPED DUE TO HIGH PACING THRESHOLDS. A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466953 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419378

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| R D274TRK ICD