BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGENCY SCX

    MDR report key: 6237047 · Received January 10, 2017

    Report

    Report Number
    2938836-2017-02254
    Event Type
    Malfunction
    Date Received
    January 10, 2017
    Date of Event
    November 22, 2016
    Report Date
    November 22, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWP
    PMA / PMN Number
    P880006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NON-DEPENDENT PATIENT THAT WAS LOST TO FOLLOW-UP PRESENTED WITH NO BATTERY DATA DURING INTERROGATION. MONITORING THE DEVICE BATTERY THROUGH MAGNET OR CONSIDERING DEVICE REPLACEMENT WAS SUGGESTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20527 REGENCY SCX IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 2408L

    Patients

    Seq Age Sex Outcome Treatment
    1