BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2953339 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01030
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    October 19, 2012
    Report Date
    November 5, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 EVENT SUMMARY THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED INTERFERENCE/NOISE. VENTRICULAR SHORT INTERVAL COUNT V-SIC=327 COUNTS, IN 10.83 DAYS, OCCURRED BETWEEN (B)(6) 2012 13:52:16 TO (B)(6) 2012 09:41:11. CONCOMITANT PRODUCTS: 6943 IMPLANTABLE TACHY LEAD (B)(6) 1999; 6937A IMPLANTABLE TACHY LEAD (B)(6) 1999; 7122 COMPETITOR IMPLANTABLE TACHY LEAD (B)(6) 2008. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEAD WAS INTERMITTENTLY CONTACTING THE RING OF A HIGH VOLTAGE LEAD, CAUSING NOISE AND OVERSENSING ON THE SENSING CIRCUIT. THE LEAD WAS CAPPED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON REMOTE TRANSMISSION THERE WAS A HIGH NUMBER OF SHORT INTERVAL COUNTS (SIC) ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55546 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R D154AWG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR