BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRAFLEX

    MDR report key: 2951355 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00018
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 8, 2012
    Report Date
    January 11, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    K894040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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: 4965 IMPLANTABLE PACING LEAD (B)(6) 2005.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS POSSIBLE PREMATURE BATTERY DEPLETION. IT WAS FURTHER REPORTED THAT THE BATTERY LONGEVITY ESTIMATION DECREASED TWO YEARS IN APPROXIMATELY THREE MONTHS. IT WAS ALSO REPORTED THAT THE VENTRICULAR LEAD HAS CHRONIC LOW IMPEDANCES AND THERE HAS BEEN AN INCREASE IN LOW IMPEDANCE PACES. THE DEVICE AND LEAD REMAIN IN USE. ADDITIONAL INFORMATION RECEIVED REPORTED CHRONIC LOW ATRIAL IMPEDANCE. THE ATRIAL LEAD 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
    57192 SPECTRAFLEX ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4951M-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00013 YR ADDRL1 IMPLANTABLE PULSE GENERATOR