BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1926218 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14235
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 13, 2010
    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
    MA, 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. ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER INSULATION WAS PULLED APART (OVERSTRESS), THE OUTER INSULATION WAS BREACHED CUT, AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD PACING WAS STIMULATING THE DIAPHRAGM. THE LEFT VENTRICULAR TRANSVENOUS LEAD WAS REMOVED AND REPLACED WITH TWO EPICARDIAL LEADS. NO 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 IMPLANTABLE PACING LEAD OJX MEDTRONIC PUERTO RICO, INC. 4196 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| R 8042 IMPLANTABLE PULSE GENERATOR| 5076 X2 IMPLANTABLE PACING LEAD