BEUDAMED
    FDA Adverse Event Death Summary report: N

    SECURA DR

    MDR report key: 2950618 · Received February 8, 2013

    Report

    Report Number
    3004209178-2013-01488
    Event Type
    Death
    Date Received
    February 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 11, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4). CONCOMITANT PRODUCT: 4470 COMPETITOR IMPLANTABLE PACING LEAD - (B)(6) 2002.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4). CONCOMITANT PRODUCT: 4470 COMPETITOR IMPLANTABLE PACING LEAD - (B)(6) 2002.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED AND DIED SIX DAYS POST IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  REPLACEMENT. INFORMATION REPORTED THAT THE PATIENT HAD COMPLICATIONS POST OPERATIVE SECONDARY TO ANESTHESIA. ADDITIONAL INFORMATION OBTAINED FROM THE PHYSICIAN'S OFFICE REPORTED THAT AT SOMETIME BETWEEN IMPLANT AND THE DATE OF DEATH THE PATIENT HAD AN EPISODE WHERE THE BLOOD PRESSURE DROPPED AND THE PATIENT'S RHYTHM WAS PULSELESS ELECTRICAL ACTIVITY. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54892 SECURA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Death 6947 IMPLANTABLE TACHY LEAD