BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFFINITY VDR

    MDR report key: 345370 · Received March 9, 2001

    Report

    Report Number
    2017865-2001-00480
    Event Type
    Malfunction
    Date Received
    March 9, 2001
    Date of Event
    January 12, 2001
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE FIELD NOTES THAT THE DEVICE DID NOT APPEAR TO BE WORKING PROPERLY. THE PATIENT WAS REFERRED TO THE CARDIOLOGIST. THE DEVICE WAS IN OVO MODE. AFTER REPROGRAMMING, THE DEVICE FUNCTIONED NORMALLY. HOWEVER, BASED ON THRESHOLDS, THE PHYSICIAN DECIDED TO REPOSITION THE LEAD. DURING REPOSITIONING, THE PATIENT LOST BLOOD PRESSURE AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10258 AFFINITY VDR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5430 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR