BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2955472 · Received February 11, 2013

    Report

    Report Number
    2182208-2013-00355
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 5, 2012
    Report Date
    March 1, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LWS
    PMA / PMN Number
    P920015
    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 VENTRICULAR (RV) LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. OVERSENSING; THERE WERE VENTRICULAR NON-SUSTAINED TACHYCARDIA OF 210 MS BETWEEN 2012 (B)(4) AND 2012 (B)(4). ONE VENTRICULAR FIBRILLATION OF 190 MS AVERAGE VENTRICULAR CYCLE WAS RECORDED ON 2012 (B)(4). INTERFERENCE/NOISE; VENTRICULAR SHORT INTERVAL COUNTS (SIC) OF 21 COUNTS IN .85 DAYS WERE CAPTURED BETWEEN 2012 (B)(4) AND 2012 (B)(4).

    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 6940 IMPLANTABLE PACING LEAD (B)(6) 2000. (B)(4).

    Additional Manufacturer Narrative · 1

    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
    58531 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS RICE CREEK MFG 6943-65

    Patients

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