BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2964779 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01404
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 5, 2012
    Report Date
    March 1, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY # THE RIGHT ATRIAL (RA) LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. THERE WERE NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS 6943 IMPLANTABLE TACHY LEAD (B)(6) 2000. (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 PATIENT INTERROGATION REVEALED NOISE ON THE RIGHT VENTRICULAR (RV) PACE/SENSE PORTION OF THE LEAD. OVERSENSING STARTED WITHIN THE LAST YEAR. THE RV LEAD WAS CAPPED AND REPLACED. IT WAS ALSO NOTED THAT DURING THE RV NOISE EPISODES, NOISE WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD ELECTROGRAM. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED ASA RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68283 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6940-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC