BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 1923188 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13298
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 7, 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
    VA, 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 AND NO ANOMALIES WERE FOUND. THERE WAS BLOOD/BODY FLUID ON THE CONDUCTORS THROUGHOUT AT VARIOUS LOCATIONS. (B)(4) THE FULL LEAD WAS RETURNED AND NO ANOMALIES WERE FOUND. THERE WAS BLOOD/BODY FLUID THROUGHOUT THE OUTER TUBING/OVERLAY AND ON THE DISTAL CONDUCTOR NEAR THE ELECTRODE END. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND (B)(4) FULL LEAD (B)(4) NO ANOMALIES FOUND (B)(4) FULL LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO UPGRADE THE PATIENT TO A CRT PACING DEVICE. THEY WERE UNABLE TO FIND A VIABLE WITH ADEQUATE PACING THRESHOLDS AND NO PHRENIC NERVE STIMULATION WITH TWO DIFFERENT LEFT VENTRICULAR LEADS. THE LEADS WERE BOTH REMOVED AND RETURNED. IT WAS ALSO REPORTED THAT THE EXISTING IMPLANTED RIGHT VENTRICULAR (RV) LEAD HAD HIGH PACING IMPEDANCES AND HAD APPARANTLY FRACTURED. THE LEAD WAS CAPPED AND A NEW RV LEAD IMPLANTED. THERE WERE NO 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 94 YR Hospitalization| R SSR303 IMPLANTABLE PULSE GENERATOR