BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOCARDIAL LEAD

    MDR report key: 3160467 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07982
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    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) IMPLANTABLE PACING LEAD (B)(6) 1994, 8042B IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 2010, (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (B)(6) 2009, 4194 IMPLANTABLE PACING LEAD (B)(6) 2004, 5866 ADAPTOR (B)(6) 1994, 6721L IMPLANTABLE TACHY LEAD (B)(6) 1994, 6721L IMPLANTABLE TACHY LEAD (B)(6) 1994, 430 COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 1993, 432 COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 1993. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEADS ARE EXPERIENCING OVERSENSING, DOUBLE COUNTING OF R-WAVES. THE PATIENT RECEIVED INAPPROPRIATE THERAPY. THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEADS EXHIBITED A HIGH NUMBER OF SHORT INTERVAL COUNTS (SIC). THE RV LEADS WERE 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
    260627 MYOCARDIAL LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 506953

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Hospitalization| L| R