BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN

    MDR report key: 2813599 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16776
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    January 15, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015/S003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS FOUND THE LEFT VENTRICULAR PACING IMPEDANCE WAS OUT OF RANGE HIGH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR [LV] LEAD HAD AN IMPEDANCE RISE OVER TWO MONTHS AND THEN THE IMPEDANCE WAS HIGH. THE THRESHOLD WAS ALSO HIGH AND A LEAD FRACTURE WAS SUSPECTED. THE LV LEAD WAS CAPPED AND REPLACED. 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 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 4193

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| D284TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD