BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT SR

    MDR report key: 4895504 · Received July 7, 2015

    Report

    Report Number
    2017865-2015-26691
    Event Type
    Injury
    Date Received
    July 7, 2015
    Date of Event
    May 26, 2015
    Report Date
    May 26, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CODE AVAILABLE. FINAL ANALYSIS FOUND THAT THE PULSE GENERATOR EXHIBITED NO OUTPUT OR TELEMETRY. BATTERY DEPLETION ALSO OCCURRED DUE TO A HIGH CURRENT DRAIN WHICH WAS CAUSED BY A LEAKY CAPACITOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED TO THE CLINIC FOR NORMAL FOLLOW-UP. THE DEVICE WAS UNABLE TO BE INTERROGATED AND EXHIBITED NO OUTPUT WHEN A CLINICIAN RAN AN EKG WITH AND WITHOUT A MAGNET. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438615 ACCENT SR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM1110 3670839

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention