BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 3100403 · Received May 8, 2013

    Report

    Report Number
    2182208-2013-01126
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    December 8, 2012
    Report Date
    May 21, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. IT WAS NOTED THE OUTER INSULATION OF THE LEAD DEVELOPED A COSMETIC DEPRESSION WHILE IN VIVO.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4): PRODUCT ID ADDRS1, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT ID 4965-15, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), EXPLANTED: 2012-(B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH/UNDEFINED IMPEDANCE AND A POTENTIAL FRACTURE WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH/UNDEFINED IMPEDANCE AND A POTENTIAL FRACTURE WAS SUSPECTED. 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
    200554 CAPSURE EPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN RICE CREEK MFG 4965-15

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 MO Hospitalization| R