BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR RF

    MDR report key: 5237160 · Received November 19, 2015

    Report

    Report Number
    2017865-2015-30322
    Event Type
    Malfunction
    Date Received
    November 19, 2015
    Report Date
    October 5, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL, NO ANOMALIES WERE NOTED.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE PMA/510(K) # SHOULD HAVE BEEN P880086 RATHER THAN P960013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZY SPELLS. DURING FOLLOW UP, THE PULSE GENERATOR EXHIBITED VENTRICULAR NOISE. ELECTROGRAMS REVEALED PACING INHIBITION DURING NOISE. THE NOISE COULD BE REPRODUCED WITH POCKET MANIPULATION. THE DEVICE WAS REPROGRAMMED. THE PATIENT WOULD BE MONITORED.

    Description of Event or Problem · 1

    NEW INFORMATION INDICATED THAT THE PULSE GENERATOR CONTINUED TO EXHIBIT NOISE, RESULTING IN PACING INHIBITION. THE PATIENT CONTINUED TO EXPERIENCE LIGHTHEADEDNESS. THE NOISE COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    NEW INFORMATION INDICATED THAT THE PULSE GENERATOR WAS EXPLANTED AND REPLACED ON (B)(6) 2016 DURING RIGHT VENTRICULAR LEAD REVISION PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES AND THE PATIENT WAS WELL POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766342 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2212 3204839

    Patients

    Seq Age Sex Outcome Treatment
    1