BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2864893 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17571
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    January 1, 2012
    Report Date
    October 19, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DISTAL SEGMENT WAS RETURNED, ANALYZED, AND THE SVC (SUPERIOR VENA CAVA) DEFIBRILLATION CONDUCTOR WAS FLEXED AND FRACTURED, THE DISTAL CONDUCTOR WAS FLEXED AND FRACTURED, AND THE RV (RIGHT VENTRICULAR) DEFIBRILLATION CONDUCTOR WAS FLEXED AND FRACTURED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCE ON THE HIGH VOLTAGE B (HVB) AND SUPERIOR VENA CAVA (SVC) COILS OF THE RIGHT VENTRICULAR (RV) LEAD WERE STABLE UNTIL NINE MONTHS AGO WHEN IMPEDANCE WENT HIGH AND HAS REMAINED THERE SINCE. REPLACEMENT IS PLANNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THERE WAS ALSO VARYING SVC IMPEDANCE VALUES, AND THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| R 7230CX IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD)