BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARSIGN¿ AMPLIFIER

    MDR report key: 7117284 · Received December 14, 2017

    Report

    Report Number
    2134265-2017-12133
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Report Date
    November 18, 2017
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    DRQ
    PMA / PMN Number
    K050006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE INVESTIGATION CONCLUSION IS DEVICE NOT RETURNED AS THE COMPLAINT DID NOT INCLUDE RETURNED DEVICE REVIEW AND LACKED THE OBJECTIVE EVIDENCE OR DESCRIPTIVE CONDITIONS OF THE EVENT REQUIRED TO DETERMINE WHAT COULD HAVE CONTRIBUTED TO THE EVENT. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR ID # 2134265-2017-12128. IT WAS REPORTED THAT INCORRECT PACING OCCURRED. IT WAS REPORTED THAT DURING AN ELECTROPHYSIOLOGY PROCEDURE INVOLVING AN LSPRO AND A NON-BSC SIMULATOR, PACING WAS DELIVERED TO THE ATRIUM; HOWEVER, PACING WAS ALSO DELIVERED TO THE VENTRICLE THOUGH A SECONDARY CATHETER LOCATED IN THE VENTRICLE. THE PHYSICIAN WAS ONLY ABLE TO RESOLVE THE SECONDARY PACING BY PHYSICALLY UNPLUGGING THE CATHETER THAT WAS LOCATED IN THE VENTRICLE IN ORDER TO ONLY PACE THE ATRIUM. IT WAS SUSPECTED THAT THE CABLE MAY HAVE BEEN INTERNALLY DAMAGED; HOWEVER NO VISUAL DAMAGE WAS OBSERVED. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896431 CLEARSIGN¿ AMPLIFIER AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL DRQ BOSTON SCIENTIFIC - FREMONT (CE) M00420012530 1906212

    Patients

    Seq Age Sex Outcome Treatment
    1