BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 1923124 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13254
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    October 1, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 THE LEAD HAD EXPERIENCED MANY MODE SWITCHES, NOISE AND OVERSENSING WAS SEEN AND HAD INSULATION FAILURE. IT WAS ALSO NOTED THAT THE PATIENT HAD AN INCREASED ARTIAL RATE. THE DEVICE WAS PROGRAMMED INCORRECTLY SO IT WAS REPROGRAMMED FROM DDDR TO MVP(R). THE LEAD AND DEVICE ARE STILL IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4524 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other| R 4024 (X2) IMPLANTABLE PACING LEAD