BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP

    MDR report key: 2780511 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13006
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P950001
    Adverse Event
    Yes
    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 THIS PATIENT EXPERIENCED CARDIOPULMONARY ARREST. UPON INTERROGATION OF THE DEVICE, A PACING FAILURE WAS NOTED WITH HIGH VENTRICULAR THRESHOLD MEASUREMENTS. AS A RESULT, THE OUT WAS REPROGRAMMED. ELECTROGRAMS REVEALED SUSPECTED VENTRICULAR TACHYCARDIA (VT). IT WAS CONSIDERED THAT IT WAS STORED AS A HIGH RATE EPISODE CAUSED BY THE PACING FAILURE. ADDITIONALLY, ELECTROGRAMS NOTED A-V DISSOCIATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4034

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4063| 1298| 4034