BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2991439 · Received March 6, 2013

    Report

    Report Number
    2182208-2013-00486
    Event Type
    Death
    Date Received
    March 6, 2013
    Date of Event
    January 1, 1997
    Report Date
    November 16, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THERE IS NO INFORMATION GIVEN AS TO THE DATE OF DEATH FOR THE PATIENT; THEREFORE, THE DATE OF DEATH INCLUDED IN THIS REPORT IS PURELY AN ESTIMATE. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: "CARDIAC STRANGULATION, A RARE COMPLICATION OF EPICARDIAL PACEMAKER LEADS DURING GROWTH." EYSKENS, MERTENS, ET AL. HEART. 1997; 77:288-289.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS LEAD MODEL. THE LEAD HAD BEEN DISCONNECTED DUE TO AN "INSULATION DEFECT." TWO YEARS LATER, THE PATIENT COMPLAINED OF "SEVERE CHEST PAIN." THE PACEMAKER FUNCTION WAS NORMAL. THE PAIN IMPROVED AFTER AN ABDOMINAL BANDAGE WAS PRESCRIBED AND PLACED. TWO WEEKS LATER, THE PATIENT COMPLAINED OF "INTENSE ABDOMINAL DISCOMFORT." THE PATIENT COLLAPSED WHILE PLAYING. THE PATIENT DIED DESPITE INTERVENTION BY MEDICAL PERSONNEL. IT WAS FOUND THAT THE LEAD HAD MADE "A LARGE LOOP ON THE ANTERIOR SURFACE OF THE HEART" AND CARVED A DEEP GROOVE IN THE HEART. THE ARTICLE STATED THAT "NECROPSY SHOWED STRANGULATION OF THE VENTRICULAR APEX BY THE EPICARDIAL LEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95001 ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 5815A

    Patients

    Seq Age Sex Outcome Treatment
    1 00006 YR Death