BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2951737 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00196
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 1, 2012
    Report Date
    February 13, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. THE PRIMARY ANALYSIS FINDING NOTED NO ANOMALIES WERE FOUND. VISUAL ANALYSIS NOTED THE LEAD HAD APPARENT EXPLANT DAMAGE.

    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).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH SUPERIOR VENA CAVA (SVC) AND RV COIL IMPEDANCE. THE LEAD WAS PARTIALLY REMOVED AND WAS REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56663 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR