BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2842964 · Received November 21, 2012

    Report

    Report Number
    2182208-2012-04044
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    November 12, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #EVALUATION SUMMARY: (B)(4). THE LEAD WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED A DISTAL CONDUCTOR FRACTURE. IT WAS FURTHER NOTED THAT THE LEAD INSULATION HAD COSMETIC DEPRESSIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD HIGH IMPEDANCE, LOSS OF CAPTURE, AND A POSSIBLE FRACTURE. 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 LEAD HAD HIGH IMPEDANCE, LOSS OF CAPTURE, AND A POSSIBLE FRACTURE. 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
    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 Hospitalization| R C2TR01 IMPLANTABLE PULSE GENERATOR