BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3050951 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04795
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    January 11, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. CONCOMITANT PRODUCTS : CD3231-40Q COMPETITOR IMPLANTABLE DEFIBRILLATOR (B)(6) 2012, 1688TC COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFECTION. THE LEFT VENTRICULAR LEAD WAS EXPLANTED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152819 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419488

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| R 0293 COMPETITOR IMPLANTABLE TACHY LEAD