BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 2810752 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-06050
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 14, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE PATIENT FELT "A KICK IN THE CHEST" AND QUESTIONED IF THE DEVICE WAS "GOING OFF." FOLLOW-UP WITH THE DEVICE CLINIC CONFIRMED THAT THE PATIENT RECEIVED ONE SHOCK DUE TO AN EPISODE OF VENTRICULAR FIBRILLATION BEING DETECTED SECONDARILY DURING AN EPISODE OF ATRIAL FIBRILLATION. THE PHYSICIAN CONSIDERED THE SHOCK NEITHER APPROPRIATE NOR INAPPROPRIATE; IT WAS APPROPRIATE FOR THE VENTRICULAR RATE, BUT THE DEVICE SHOULD HAVE BEEN PROGRAMMED DIFFERENTLY. NO DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES WERE NOTED. THE DEVICE WAS REPROGRAMMED AND THE PATIENT MEDICATION WAS CHANGED. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R 6947 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD