BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRAFLEX

    MDR report key: 2203000 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11601
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K790429
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE VISIT, THE PATIENT COMPLAINED OF WEAKNESS AND THERE WAS UNIDENTIFIED IMPEDANCE AND NO CAPTURE OF THE RIGHT VENTRICULAR (RV) LEAD. AN X-RAY CONFIRMED THE CONNECTOR PIN OF THE RV LEAD HAD PULLED COMPLETELY OUT OF THE DEVICE HEADER. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE LEAD REMAINS IN USE. NO FURTHER 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. 6957 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R 4057M IMPLANTABLE PACING LEAD