BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGENCY

    MDR report key: 3920402 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14040
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    April 11, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    P880006
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTERROGATION, THE PULSE GENERATOR EXHIBITED TELEMETRY INAPPROPRIATE MEASURED DATA. THE BATTERY DATA WAS NOT DISPLAYED EXCEPT MAGNET RATE. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397511 REGENCY IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 2408L NA

    Patients

    Seq Age Sex Outcome Treatment
    1