BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EP-4 STIMULATOR

    MDR report key: 1638491 · Received March 18, 2010

    Report

    Report Number
    2248049-2010-00001
    Event Type
    Malfunction
    Date Received
    March 18, 2010
    Date of Event
    February 24, 2010
    Report Date
    February 24, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    JOQ
    PMA / PMN Number
    K041442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE IN THE PROCESS OF INVESTIGATING THIS EVENT. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPETITION OF OUR INVESTIGATION. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: 03/18/2010. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(6) 2010.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EP-4 STIMULATOR EP-4 STIMULATOR JOQ ST. JUDE MEDICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other