BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBQ

    MDR report key: 4970658 · Received August 5, 2015

    Report

    Report Number
    2649622-2015-08425
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 1, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS RECEIVED FROM A COMPETITOR. ALL DATA PERTINENT TO THE EVENT IS PROVIDED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: PRODUCT ID: N161, ICD, IMPLANTED: (B)(6) 2014. PRODUCT ID: 2088TC, LEAD, IMPLANTED: (B)(6) 2014. PRODUCT ID: 1258T, LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBCUTANEOUS LEAD HAD HIGH IMPEDANCE. A FRACTURE WAS CONFIRMED ON FLUOROSCOPY. THE LEAD WAS REMOVED AND A NEW SUBCUTANEOUS LEAD WAS ATTEMPTED. THE NEW SUBCUTANEOUS LEAD FAILED TO CAPTURE AND THE PHYSICIAN CHOSE TO USE A DIFFERENT LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513466 SUBQ DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6996SQ58

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| R 7122 LEAD