BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 5272389 · Received December 7, 2015

    Report

    Report Number
    2938836-2015-32255
    Event Type
    Injury
    Date Received
    December 7, 2015
    Date of Event
    November 18, 2015
    Report Date
    November 18, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH REMOTE TRANSMISSION THAT DECREASED R-WAVE AMPLITUDE AND EPISODES OF NON-SUSTAINED VENTRICULAR OVERSENSING CAUSED BY P-WAVE OVERSENSING WERE OBSERVED. LEAD DISLODGEMENT WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802816 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7122Q/58 A000000765

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention