BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN BIPOLAR OVER THE WIRE LEAD

    MDR report key: 2790350 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15016
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Report Date
    October 14, 2019
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015/S012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION AND THE DEVICE MET EXPECTED LONGEVITY.

    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 THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) PREMATURELY. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE THRESHOLD WAS HIGH ON BOTH THE RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEADS, AND THERE WAS A POTENTIAL CONCERN ABOUT THE PERFORMANCE OF THE LV LEAD. DURING THE DEVICE CHANGE THE PHYSICIAN EVALUATED THE LEADS. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THE LEFT VENTRICULAR (LV) LEAD WAS TURNED OFF AND LATER CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN BIPOLAR OVER THE WIRE LEAD PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD