BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBQ

    MDR report key: 3861745 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01751
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 PRODUCTS: PRODUCT ID: 694765 LEAD, IMPLANTED: (B)(6) 2008. PRODUCT ID: DDBC3D1 ICD, IMPLANTED: (B)(6) 2014. D224DRG ICD, IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH IMPEDANCE ON THE SUPERIOR VENA CAVA (SVC) COIL. DURING THE DEVICE CHANGE OUT, THE SVC MEASURED "NONE". THE LEAD WAS KEPT IN THE NEW SYSTEM AND WAS TURNED OFF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341667 SUBQ DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6996SQ58

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R 1688T COMPETITOR LEAD