BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2853665 · Received December 3, 2012

    Report

    Report Number
    2182208-2012-04051
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 16, 2012
    Report Date
    February 18, 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

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE PARTIAL LEAD WAS RETURNED IN SEGMENTS AND WAS ANALYZED. ANALYSIS REVEALED A BREACHED DEPRESSION OF THE OUTER INSULATION. IT WAS NOTED THERE WAS COSMETIC DEPRESSION OF THE OUTER INSULATION AND A WHITE SUBSTANCE ON THE OUTER INSULATION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. FOR USE BY USER FACILITY/IMPORTER (DEVICES ONLY). (B)(4). CONCOMITANT PRODUCT: 4968, IMPLANTABLE PACING LEAD 2005 (B)(6). THE LEAD WAS NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT VENTRICULAR OVERSENSING OCCURRED WHEN THE PATIENT WOULD SIT UP OR CONTRACT THE ABDOMEN. IT WAS FURTHER REPORTED THAT DIAPHRAGMATIC STIMULATION OCCURRED WITH ATRIAL OVERSENSING AND THAT A LEFT VENTRICULAR LEAD WARNING OCCURRED FOR LOW IMPEDANCE. THE LEADS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT VENTRICULAR OVERSENSING OCCURRED WHEN THE PATIENT WOULD SIT UP OR CONTRACT THE ABDOMEN. IT WAS FURTHER REPORTED THAT DIAPHRAGMATIC STIMULATION OCCURRED WITH ATRIAL OVERSENSING AND THAT A LEFT VENTRICULAR LEAD WARNING OCCURRED FOR LOW IMPEDANCE. THE LEADS WERE REMOVED 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
    1 CAPSURE EPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN RICE CREEK MFG 4965

    Patients

    Seq Age Sex Outcome Treatment
    1 00009 YR Hospitalization| R 4968 IMPLANTABLE PACING LEAD