BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2953778 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01258
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    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 CONTINUED: 5076-52 IMPLANTABLE PACING LEAD (B)(6) 2002; 5068-58 IMPLANTABLE PACING LEAD (B)(6) 2002; 2187-85 IMPLANTABLE PACING LEAD (B)(6) 2002. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT ONE LEAD WAS NEVER PUT IN THE BEST POSITION AND SINCE THEN HAS USED HIGH ENERGY TO STIMULATE HEART. FOLLOW-UP ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE CLINIC ARE IN PROGRESS. NO INFORMATION HAS BEEN RECEIVED AT THIS POINT. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT FOLLOW-UP INFORMATION WAS RECEIVED FROM THE CLINIC THAT DISCLOSED THE LEFT VENTRICULAR (LV) LEAD WAS IMPROPERLY PLACED AT INITIAL IMPLANT AND HAD POOR CONTACT. THE OUTPUT WAS REPROGRAMMED. 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
    55443 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5068-58

    Patients

    Seq Age Sex Outcome Treatment
    1 C2TR01 IMPLANTABLE PULSE GENERATOR