BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 2050673 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05400
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT ALL CONDUCTORS WERE DISTORTED, ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION. (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED AND FOUND THE HELIX DISENGAGED FROM HELICAL CHANNEL. THE INNER TUBING WAS KINKED/BUCKLED, THERE WAS BLOOD IN/ON THE HELIX/LOB MECHANISM (SLEEVE HEAD), AND BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    POCKET EROSION WAS REPORTED. THE LEADS WERE REMOVED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE RIGHT VENTRICULAR LEAD WAS RETURNED, ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION.

    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 87 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB