BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3212470 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08526
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 31, 2013
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE REMAINS IN SERVICE HAS NOT BEEN RETURNED AND THEREFORE A TECHNICAL ANALYSIS CANNOT BE CONDUCTED. WITHOUT A RETURNED DEVICE IT IS NOT POSSIBLE TO DEFINITELY CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. 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 THE PATIENT WITH THIS DEVICE WAS EXPERIENCING VENTRICULAR TACHYCARDIA (VT) EPISODES AND WAS SUBSEQUENTLY HOSPITALIZED. THE DEVICE WAS THEN INTERROGATED AND A REVIEW OF AN ELECTROGRAM (EGM) FOUND THE DEVICE HAD UNDERSENSED THE PATIENT FOR AN UNKNOWN DURATION. THE PATIENT HAD TO BE EXTERNALLY SHOCKED TO REVERT TO THEIR OWN INTRINSIC RHYTHM. THE DEVICE WAS THEN REPROGRAMMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311905 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT PUERTO RICO BV K187

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R