BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 3053225 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05440
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    G050163
    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 LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED AND REPLACED DUE TO MICRODISLODGEMENT WITH LOSS OF CAPTURE. THE LOSS OF CAPTURE WAS DETECTED AT A PREVIOUS FOLLOW-UP. REPROGRAMMING CONFIGURATION WAS UNSUCCESSFUL AT 7.5V IN ANY CONFIGURATION. THE PATIENT HAS A REQUIREMENT FOR BI-VENTRICULAR PACING THERAPY; HOWEVER DID NOT HAVE ANY ADVERSE EFFECTS AS A RESULT OF THE LOSS OF CAPTURE. THE EXPLANTED LEAD WAS REPLACED WITH A NON-BOSTON SCIENTIFIC LEAD, AND THE EXPLANTED LEAD WAS DISCARDED AT THE FACILITY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156805 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 0185| 4096| 4543| 4592| P107| MISMATCH