BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOCARDIAL LEAD

    MDR report key: 3157566 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-07687
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. CONCOMITANT PRODUCTS: 6721L-50 X2 IMPLANTABLE TACHY LEADS 1995 (B)(6); 5866 ADAPTOR 1995 (B)(6); 5069-35 IMPLANTABLE PACING LEAD 1995 (B)(6); 430 COMPETITOR IMPLANTABLE PACING LEAD 1997 (B)(6); (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 2008 (B)(6); (B)(4) IMPLANTABLE PACING LEAD 2001-08-03 1688T COMPETITOR IMPLANTABLE PACING LEAD 2007 (B)(6); 4196-88 IMPLANTABLE PACING LEAD 2011 (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE PATIENT CALLED AND INQUIRED ABOUT THE EPICARDIAL PATCH LEADS IMPLANTED IN 1995 REPORTING THAT THE PHYSICIAN HAD STATED THAT ¿THE ELECTRICAL IMPULSES GIVEN OFF BY THE LEAD OR THE DEVICE THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AFFECTED THE BEATS OF THE HEART BUT WAS UNDETECTABLE BY ECHO OR INTERROGATION. HE DID SAY THAT IT WAS SENT TO THE HEART THEY COULDN'T SEE IT ANYWHERE.¿FOLLOW UP WAS CONDUCTED WITH THE PHYSICIAN AND IT WAS REPORTED THAT PATIENT HAD BOTH A PACEMAKER AND AN ABDOMINAL ICD. THE PATIENT WAS EXPERIENCING ABDOMINAL FULLNESS AND DISCOMFORT AND THE FOUR ICD LEADS WERE NO LONGER WORKING WELL WITH HIGH IMPEDANCE SO THE DECISION WAS MADE TO EXPLANT BOTH DEVICES AND UPGRADE THE PATIENT TO ONE PECTORAL DEVICE AND TO REMOVE ALL OF THE ABDOMINAL ICD LEADS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255547 MYOCARDIAL LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 506935

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R