BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBQ

    MDR report key: 4241476 · Received November 10, 2014

    Report

    Report Number
    2182208-2014-03134
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    November 6, 2014
    Report Date
    November 6, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION COIL DISPLAYED VARIABLE AND HIGH IMPEDANCE. A FRACTURE WAS SUSPECTED. THE COIL WAS CAPPED AND A DEFIBRILLATION PATCH WAS ADDED POSTERIOR AND INFERIOR TO THE HEART. THE PATIENT'S CHEST WAS CLOSED AND DEFIBRILLATION THRESHOLD TESTING WAS PERFORMED USING THE EXISTING IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT VENTRICULAR (RV) LEAD AND NEW DEFIBRILLATION PATCH. AT MAXIMUM OUTPUT DEFIBRILLATION DID NOT RESCUE THE PATIENT AND EXTERNAL DEFIBRILLATION WAS REQUIRED. THE PATIENT'S CHEST WAS REOPENED AND A SECOND PATCH WAS ADDED TO THE ANTERIOR PORTION OF THE HEART. DEFIBRILLATION TESTING WAS DEFERRED TO A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722808 SUBQ DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6996SQ58

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR Hospitalization| R D314DRG ICD, 693558 LEAD, 5076-45 LEAD