BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 6162009 · Received December 9, 2016

    Report

    Report Number
    2649622-2016-14899
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    February 14, 2014
    Report Date
    September 27, 2016
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 694758 LEAD, IMPLANTED: (B)(6) 2013; 407652 LEAD, IMPLANTED: (B)(6) 2013. EVALUATION SUMMARY: ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND, HOWEVER VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE; FULL LEAD RETURNED AND ANALYZED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE CHRONIC HIGH THRESHOLDS ON THE LV (LEFT VENTRICULAR) LEAD, RESULTING IN HIGH LV OUTPUTS. PREMATURE BATTERY DEPLETION WAS ALSO REPORTED. THE DEVICE AND LV LEAD WERE EXPLANTED AND REPLACED. IN THE COURSE OF REVISING THE LV LEAD, THE ATRIAL LEAD BECAME DISLODGED, SO IT WAS ALSO EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812565 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R D314TRG CRT-D