BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

    MDR report key: 3051209 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04827
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    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 THERAPY: MODEL 5086MRI45 IMPLANTABLE PACING LEAD, IMPLANT DATE (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND NO ANOMALIES WERE FOUND. PERFORMED ELECTRICAL CONTINUITY AND CROSS CONTINUITY FOR DISTAL AND PROXIMAL PORTIONS AND ALL PASSED, ELECTRICALLY. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION DUE TO A RIGHT VENTRICULAR (RV) LEAD PERFORATION. IT WAS ALSO REPORTED THAT THERE WAS A LOSS OF CAPTURE. THE RV LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151966 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI52

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| L| R RVDR01 IMPLANTABLE PULSE GENERATOR| MODEL RVDR01 IMPLANTABLE PULSE GENERATOR