BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE

    MDR report key: 3963602 · Received July 29, 2014

    Report

    Report Number
    2649622-2014-07673
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 4, 2014
    Report Date
    August 20, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY # PRODUCT ID# 383059 A PROXIMAL PORTION WAS RECEIVED MEASURING 7.7 CM. A DISTAL PORTION WAS RECEIVED MEASURING 41.5 CM. THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO.

    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 DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) EARLY. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD HIGH THRESHOLDS, A RISE IN IMPEDANCE WITH LOSS OF CAPTURE DUE TO A POSSIBLE LEAD FRACTURE. THE DEVICE WAS EXPLANTED AND REPLACED. THE RA LEAD WAS EXPLANTED AND DURING THE REPLACEMENT WITH A NEW RA LEAD THERE WAS SUSPICION OF A PERFORATION. THE RA LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD FOR SAFETY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442503 SELECTSECURE DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 383059

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR Hospitalization| L| R (B)(4) IPG