BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE

    MDR report key: 3860664 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05351
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    October 30, 2013
    Report Date
    March 7, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. PRODUCTS: ADDRL1 IPG IMPLANTED: 2013 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED AND THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. THE PROXIMAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING; THE OUTER INSULATION OF THE PROXIMAL CONDUCTOR OF THE LEAD WAS EXTRINSICALLY CUT BUT NOT BREACHED. THE OUTER INSULATION OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION; VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. ELECTRICAL RESISTANCE AND CROSS CONTINUITY TEST RESULTS WERE WITHIN SPECIFICATION. VISUAL INSPECTION FOUND OUTER INSULATION BREACHED AND BLOOD INGRESSION. THE BREACHED INSULATION DID CONTRIBUTE TO THE ELECTRICAL COMPLAINTS OF HIGH THRESHOLDS AND SENSING AND IT APPEARS TO HAVE BEEN CAUSED AT THE IMPLANT.

    Description of Event or Problem · 1

    2014 (B)(6), 07:14:57 (B)(4) IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXPERIENCED RISING THRESHOLDS SINCE IMPLANT UNTIL THERE WAS TOTAL LOSS OF CAPTURE AND SENSING. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340449 SELECTSECURE DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 383069

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Hospitalization| R 5076 LEAD