BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1803284 · Received August 17, 2010

    Report

    Report Number
    2649622-2010-08825
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    June 4, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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) NO ANOMALIES FOUND; PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED. BLOOD/BODY FLUID WAS PRESENT ON ALL CONDUCTORS. PARTIAL LEAD IN SEGMENTS. (B)(4) NO ANOMALIES FOUND. THE PROXIMAL CONDUCTOR HAD BLOOD, OUTER INSULATION MELTED. PARTIAL LEAD IN SEGMENTS WAS RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND. THE PROXIMAL CONDUCTOR DISTORTED AND BLOOD ON PROXMIAL CONDUCTOR. THE MEDIAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEADS WERE EXPLANTED AND REPLACED DUE TO INFECTION. THERE WERE NO LEAD ISSUES REPORTED AND NO FURTHER PATIENT COMPLICATIONS 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 MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention 3830 X 2 IMPLANTABLE PACING LEADS| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6935 IMPLANTABLE TACHY LEAD