BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2953662 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01299
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 17, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 CONTINUED: 4592 IMPLANTABLE PACING LEAD (B)(6) 2007. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT SUMMARY EVENT: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED THAT THE LEAD¿S THRESHOLD READINGS WERE ABOVE 2.5 VOLTS.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE RV LEAD IMPEDANCE VALUES WERE DECLINING. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE PATIENT'S FOLLOW-UP VISIT THE RIGHT VENTRICULAR (RV) LEAD'S THRESHOLDS HAVE INCREASED AND ARE WORSENING. WHEN CHECKING THE LEAD IN BIPOLAR AND UNIPOLAR IT WAS NOTED THAT THE PATIENT GETS POCKET STIMULATION IN UNIPOLAR; THEREFORE, THAT ISNOT AN OPTION. THE LEAD REMAINS IN USE AND WILL BE MONITORED. PATIENT SCHEDULED FOR ANOTHER CHECK IN LESS THAN A MONTH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56371 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407658

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR (B)(4) IMPLANTABLE PULSE GENATOR