BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2954715 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01515
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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). PRODUCT: 4296 IMPLANTABLE PACING LEAD (B)(6) 2012; 5076 IMPLANTABLE PACING LEAD (B)(6) 2012.

    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) COIL IMPEDANCE WAS GREATER THAN 200 OHMS. THE RV COIL TREND WAS NORMALLY AROUND 38OHMS. A REVIEW OF AN X-RAY SHOWED THAT ALL OF THE LEAD PINS EXTENDED BEYOND THE CONNECTOR BLOCKS. CLOSE MONITORING OF THE LEAD WAS RECOMMENDED AND IT REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58816 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6942-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR D314TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR