BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2954569 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02348
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    December 18, 2012
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. (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 THE DEVICE WAS AT ERI (ELECTIVE REPLACEMENT INDICATOR) EARLIER THAN EXPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLDS THAT INCREASED OVER TIME. IT WAS NOTED THAT THIS INCREASE MOST LIKELY CONTRIBUTED TO THE EARLY ERI OF THE DEVICE. 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
    58190 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 6943 IMPLANTABLE TACHY LEAD