BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 3153479 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06046
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 PACING LEAD, (B)(6) 2010; (B)(4) IMPLANTABLE TACHY LEAD, (B)(6) 2004. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD DISLODGED. THE 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
    256939 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419688

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R (B)(4) IMPLANTABLE CRT-D