BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1853162 · Received September 30, 2010

    Report

    Report Number
    2649622-2010-09079
    Event Type
    Injury
    Date Received
    September 30, 2010
    Report Date
    January 25, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION # (B)(4) FOR A 2 YEAR RETROSPECTIVE REVIEW OF REPORTED EVENTS WHERE THE PRODUCT WAS STILL IN USE; DATE RANGE (B)(6) 2008 AND (B)(6) 2010. THIS MEDWATCH REPORT REPRESENTS 1 OF 11 EVENTS (EVENT TYPE CODE SERIOUS INJURY). THIS EVENT OCCURRED OUTSIDE THE US. ALL INFO PROVIDED IS INCLUDED IN THIS REPORT. IF ADD'L RELEVANT INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PT INFO IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED "PHRENICUS STIMULATION". THE LEAD WAS REPROGRAMMED. THE PT OUTCOME WAS LISTED AS "RESOLVED". NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN ABILITY IMPLANTABLE PACING LEAD/OJX OJX MEDTRONIC PUERTO RICO, INC. 4196

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention