BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 2964668 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01962
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 6, 2012
    Report Date
    February 19, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY (B)(4) - THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. THE PRIMARY ANALYSIS FINDING NOTED NO ANOMALIES WERE FOUND.

    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 CONTINUED: 0125 COMPETITOR IMPLANTABLE TACHY LEAD 1997-(B)(6), 5076-52 IMPLANTABLE PACING LEAD 2002-(B)(6), (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD WAS REPOSITIONED SEVERAL TIMES IN THE LARGE LATERAL BRANCH, BUT AN OPTIMAL POSITION COULD NO LONGER BE FOUND AS THERE WAS DIAPHRAGMATIC STIMULATION AND POOR CAPTURE THRESHOLDS THROUGHOUT. THE LV LEAD WAS NOT IMPLANTED AND WAS REPLACED WITH A SMALLER LEAD WHICH WAS ADVANCED INTO A SMALLER SUB-BRANCH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS THE RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66393 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| R D334TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR