BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE

    MDR report key: 3213025 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10379
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 30, 2013
    Report Date
    June 30, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 THAT DURING A ROUTINE FOLLOW-UP, IT WAS NOTED THE DEVICE HAD NOT MODE SWITCHED CORRECTLY AS THE RIGHT ATRIAL (RA) LEAD WAS EXHIBITING IMPEDANCE MEASUREMENTS OF 100 OHMS. THERE WAS ALSO UNDERSENSING OF THE ATRIAL FIBRILLATION (AF) RESULTING IN OCCASSIONAL PACING AT HIGH RATES FOR SHORT PERIODS OF TIME. THE DEVICE WAS REPROGRAMMED TO DDI MODE. AFTER SOME DISCUSSION WITH THE PATIENT, IT WAS REVEALED THAT VALVE REPLACEMENT SURGERY OCCURRED 3-4 WEEKS EARLIER. PRIOR TO THE SURGERY, ALL MEASUREMENTS WERE APPROPRIATE. AS A RESULT, IT WAS SUSPECTED THE LEAD WAS DAMAGED DURING THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313478 SELUTE IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4294

    Patients

    Seq Age Sex Outcome Treatment
    1 4294| 4035