BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 3991383 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14297
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-0115-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. CONCOMITANT MEDICAL PRODUCTS: 407652, LEAD, (B)(6) 2010. (B)(4). THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT DETERMINE THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS AFTER IMPLANT, THE PATIENT PRESENTED WITH EROSION AT THE DEVICE POCKET AND LOCAL INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND TWO LEADS WERE EXPLANTED. DURING THE EXTRACTION THE SUPERIOR VENA CAVA (SVC) DISSECTED REQUIRING OPEN CHEST REPAIR. THE PATIENT ALSO EXPERIENCED A PERICARDIAL EFFUSION AND HEMOTHORAX. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471407 SECURA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| L| R 694765 LEAD