BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 2791292 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15114
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 22, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006/S002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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. EVALUATION SUMMARY: (B)(4) - THE FULL LEAD WAS RETURNED, ANALYZED AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. ALSO NOTED WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFECTION OCCURRED. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN ABILITY PLUS IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4296

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD