BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOCARDIAL LEAD

    MDR report key: 3160422 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07981
    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. PRODUCT: 5069 IMPLANTABLE PACING LEAD (B)(6) 1994; 8042B IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 2010; D224TRK 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
    259332 MYOCARDIAL LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 506953

    Patients

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