BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 2952260 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00154
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 15, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTD
    PMA / PMN Number
    K904575
    Adverse Event
    Yes
    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. EVALUATION SUMMARY: (B)(4) THE FULL LEAD 5866-38M WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED) AND THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED). (B)(4) IMPLANTABLE PULSE GENERATOR (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TWO EPICARDIAL LEFT VENTRICULAR LEADS AND AN ADAPTOR. SINCE THE IMPLANT OF THE LEADS AND ADAPTOR THERE HAS BEEN A PROGRESSIVE INCREASE IN THRESHOLDS. THE ADAPTOR WAS REMOVED AND THE LEADS WERE PARTIALLY REMOVED, CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57066 NONE ADAPTOR, LEAD, PACEMAKER DTD RICE CREEK MFG 5866-38M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 5071 X 2 IMPLANTABLE PACING LEADS