BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2953190 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00966
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    October 12, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    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: 4076 IMPLANTABLE PACING LEAD: (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED TWICE SINCE IMPLANT, AND THAT THE PATIENT EXPERIENCED DIZZINESS AND P RE-SYNCOPE AS A RESULT. THE SYMPTOMS WERE RESOLVED WHEN THE DEVICE WAS CHANGED TO UNIPOLAR PACING AND MAXIMUM PACING OUTPUT. IT WAS NOTED THAT THE PATIENT'S SIZE AND WEIGHT WERE A FACTOR IN THE DISLODGEMENTS. THE PASSIVE FIXATION LEAD WAS EXPLANTED AND REPLACED BY AN ACTIVE FIXATION LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56978 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4092-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R ADDRS1 IMPLANTABLE PULSE GENERATOR (IPG)