BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 6401565 · Received March 13, 2017

    Report

    Report Number
    2017865-2017-01678
    Event Type
    Malfunction
    Date Received
    March 13, 2017
    Date of Event
    February 9, 2017
    Report Date
    October 7, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (PMA/510(K) SHOULD BE # P880086 RATHER THAN BLANK,

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CORRECTION: SHOULD HAVE BEEN 2088TC/52, BFB026411 THERAPY DATE OF (B)(6) 2017 RATHER THAN BLANK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP, THE PULSE GENERATOR EXHIBITED NOISE. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182758 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2212 3279427

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR 2088TC/52, (B)(4)