BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3993373 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09347
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE LV (LEFT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE, AND PACING CAPTURE THRESHOLD IN THE LV (LEFT VENTRICLE) WAS HIGH. LEFT VENTRICULAR CAPTURE MANAGEMENT SHOWS HIGH THRESHOLDS (GREATER THAN 2.5V) FOR THE WEEK ENDING 18-JUN-2014. MIN/MAX LV PACE IMPEDANCE TREND IS APPROXIMATELY 500 OHMS. MAXIMUM IMPEDANCE IS GREATER THAN 3000 OHMS STARTING THE WEEK OF 04-JUN-2014.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 6947 LEAD IMPLANTED 2007-(B)(6); D224TRK ICD IMPLANTED 2012-(B)(6).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THERE WAS INTERMITTENT CAPTURE AND FRACTURE WAS CONFIRMED. THE LEAD WAS CAPPED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ALERT DUE TO HIGH IMPEDANCE ON THE LEFT VENTRICULAR (LV) LEAD AND FRACTURE WAS SUSPECTED. A VENOGRAM FOUND THAT THERE WAS LEFT AND RIGHT SIDE OCCLUSION, SO THERE IS A PLAN TO DO VENOPLASTY AND ATTEMPT A NEW LEAD ON THE RIGHT. IF VENOPLASTY IS UNSUCCESSFUL THE PATIENT WILL BE REFERRED FOR EPICARDIAL LEADS. THE LV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470862 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419388

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization| R 5076 LEAD