BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVENE

    MDR report key: 4399120 · Received January 8, 2015

    Report

    Report Number
    2124215-2014-21305
    Event Type
    Injury
    Date Received
    January 8, 2015
    Date of Event
    November 20, 2014
    Report Date
    November 25, 2014
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    LWS
    PMA / PMN Number
    P940008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE DEVICE IS RETURNED ANALYSIS WILL BE PERFORMED AND THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT RECEIVED TWO SHOCKS FOR VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF). THE PHYSICIAN WAS QUESTIONING IF THE PACING WAS CAUSING THE PATIENT'S VT; IT WAS NOTED THAT THE LOWER RATE LIMIT WAS PROGRAMMED TO 40 PACES PER MINUTE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE ELECTROGRAM STRIPS AND FOUND THAT THE DEVICE WAS PACING APPROPRIATELY. HOWEVER, SHORTLY AFTER THE PACE, THE VT AND VF STARTS. TS WAS UNABLE TO DETERMINE IF THIS WAS DUE TO THE PATIENT HAVING A PAUSE-DEPENDENT VT EXACERBATED BY THE PACING OR IF THE PACING WAS THE CAUSE OF THE VT. THE FOLLOWING DAY THE PATIENT FELL AFTER RECEIVING APPROPRIATE THERAPY FOR VF. THE REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS AND A LOW SHOCK IMPEDANCE WHEN ATTEMPTING TO DELIVER A SHOCK, THUS THE PATIENT WAS HOSPITALIZED. UPON INTERROGATION, THE LOW OUT OF RANGE PACING AND SHOCKING IMPEDANCES ALONG WITH LOSS OF CAPTURE WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD AND DEVICE. A SHORTED LEAD INDICATOR MESSAGE ALSO DISPLAYED, INDICATING THAT ALTHOUGH THE DEVICE HAD GIVEN THERAPY FOR THE VF, IT HAD SHOCKED INTO A SHORTED LEAD. TS WAS CONSULTED AND RECOMMENDED DEVICE AND LEAD REPLACEMENT. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED WHERE BOTH THE DEVICE AND LEAD WERE EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18361 INTERVENE IMPLANTABLE LEAD LWS GUIDANT ANGLETON/ST. PAUL 497-23

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R E030| 1860| 101-10| 497-23