BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRAFLEX

    MDR report key: 2122550 · Received June 13, 2011

    Report

    Report Number
    2649622-2011-07874
    Event Type
    Injury
    Date Received
    June 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K812599
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4), THE PROXIMAL SEGMENT WAS RETURNED AND ANALYZED. THE DISTAL CONDUCTOR WAS FRACTURED. IT WAS ALSO NOTED THAT THE DISTAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), AND OUTER INSULATION HAD COSMETIC METAL INDUCED OXIDATION. THE ANALYST NOTED THAT THEY WERE UNABLE TO DETERMINE THE LOCATION OF THE ANCHOR SLEEVE.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED FOR UNSPECIFIED REASON AND LEAD STATUS REPLACEMENT IS UNKNOWN AT THIS TIME DUE TO NO PATIENT/DOCTOR NAME AND LEAD SERIAL NUMBER DID NOT REGISTER IN DEVICE IMPLANT QUERY (DIQ). THE PROXIMAL SEGMENT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRAFLEX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4951 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R LEAD/COMP IMPLANTABLE PACING LEAD