BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3082645 · Received April 29, 2013

    Report

    Report Number
    2124215-2013-07038
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY THE LEAD HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE LEAD HAD FRACTURED. ANOTHER MANUFACTURER'S FIELD REPRESENTATIVE REPORTED THAT THE LEAD HAD DISPLAYED IMPEDANCE ISSUES. THE PATIENT WAS TO UNDERGO A LEAD EXTRACTION PROCEDURE AND BE REPLACED WITH ANOTHER MANUFACTURES PRODUCT. THE FIELD REPRESENTATIVE INDICATED THE LEAD WOULD BE RETURNED FOR ANALYSIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185752 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 273 MO Hospitalization| L| R T167| 4087| MISMATCH| 0185