BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRAFLEX

    MDR report key: 2944950 · Received February 6, 2013

    Report

    Report Number
    2182208-2013-00016
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    K894040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT ATRIAL (RA) EPICARDIAL PACING LEAD EXPERIENCED LOW IMPEDANCE, WAS OVERSENSING FAR FIELD R WAVES (FFRW) AND UNDERSENSING P WAVES. THE RIGHT VENTRICULAR (RV) EPICARDIAL PACING LEAD HAD HIGH PACING THRESHOLDS. THE RA AND RV LEADS WERE CAPPED AND REPLACED. DURING THE PROCEDURE, THE REPLACEMENT EPICARDIAL LEAD'S TIP WAS UNABLE TO BE SEATED INTO THE APPLICATOR PRIOR TO THE LEAD'S IMPLANT. THE LEAD WAS DISCARDED AND A NEW LEAD WAS PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50899 SPECTRAFLEX ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4951M

    Patients

    Seq Age Sex Outcome Treatment
    1 00021 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR