BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2053151 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-05489
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 3, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION VIA THEIR LITERATURE REVIEW PROCESS, THAT THESE TWO RIGHT VENTRICULAR LEADS EXHIBITED SENSING ISSUES AND ULTIMATELY NEEDED TO BE REPLACED. DURING THE EXTRACTION PROCESS OF THE FINELINE II PRODUCT, THE LEAD MANIFESTED AN APPARENT FRACTURE. NO FURTHER DETAILS ON THE ENDOTAK RELIANCE LEAD PROVIDED WITHIN THE CONTEXT OF THE ARTICLE; HOWEVER, IT WAS MENTIONED THE LEAD WAS REMOVED FOR A SIMILAR ANOMALY. THE AUTHOR OF THE PUBLICATION WAS CONTACTED HOWEVER, UNABLE TO PROVIDE THE ASSOCIATED SERIAL NUMBERS OF THE LEADS, SO AS TO CROSS REFERENCE OUR INTERNAL COMPLAINT HANDLING SYSTEM FOR PREVIOUSLY ENTERED INFORMATION. WHILE NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED, THE LEAD WAS REMOVED VIA THE FEMORAL APPROACH WITH A LASER TECHNIQUE, AS WAS THE DISCUSSION OF THIS PUBLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY GUIDANT PUERTO RICO BV 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention