BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3904360 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09331
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PATIENTS PHYSICIAN CALLED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONCERNED WITH LOSS OF CAPTURE (LOC) AND STATED THAT THE FAMILY OF THIS PATIENT SAID THEY HAD BEEN EXPERIENCING SYNCOPAL EVENTS. THE PHYSICIAN ALSO STATED THAT THE PATIENT WENT INTO ATRIAL FLUTTER AND HAD NOT BEEN FEELING WELL. CURRENTLY THE PATIENT IS INHIBITING PACING IN THE LEFT VENTRICLE AND WOULD LIKE TO GET MORE BI-VENTRICULAR (BIV) PACING GOING FOR THIS PATIENT. TS SUGGESTED SOME PROGRAMMING CHANGES WHICH THE PHYSICIAN DID, BUT WAS STILL SEEING AN OCCASIONAL PREMATURE VENTRICULAR CONTRACTIONS (PVC) BUT THERE WAS INCREASED BIV PACING. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383774 INGENIO IMPLANTABLE CHF GENERATOR LWP GUIDANT CRM CLONMEL IRELAND V173

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| R V173| 4968| 4136| 4135| 1290