BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRAFLEX

    MDR report key: 2212277 · Received August 15, 2011

    Report

    Report Number
    2182208-2011-02005
    Event Type
    Injury
    Date Received
    August 15, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    K894040
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH LEADS HAD A FRACTURE, NO CAPTURE AT MAXIMUM OUTPUTS, AND INCREASED IMPEDANCES. THE RIGHT ATRIAL LEAD HAD AN INCREASE TO 5000 OHMS SINCE THE INTERROGATION OF THE DEVICE TWO YEARS AGO. THE LEADS WERE CAPPED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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, INC. 4951M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| R SDR303 IMPLANTABLE PULSE GENERATOR