BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 2850722 · Received November 23, 2012

    Report

    Report Number
    1000165971-2012-00448
    Event Type
    Injury
    Date Received
    November 23, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 2, 2012
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, DURING AN ICD REPLACEMENT BECAUSE OF NORMAL BATTERY DEPLETION, LEADS WERE DISCONNECTED FROM THE OLD ICD, AND THE ATRIAL LEAD WAS CONNECTED FIRST TO THE ICD INVOLVED IN THIS MDR REPORT. THEN THE VENTRICULAR LEAD (IS-1) WAS CONNECTED; HOWEVER, CLICK SOUND OF THE SCREWDRIVER WAS NOT CONFIRMED WHEN SETSCREW WAS TIGHTENED. THE PHYSICIAN TOOK OUT THE SCREWDRIVER FROM THE SLOT AND RE-INSERTED IT AGAIN; CLICK SOUND WAS NOT CONFIRMED AGAIN. THE LEAD COULD NOT BE REMOVED FROM THE PORT WITH A LEAD PULL TEST. BECAUSE THERE WAS NO CLICK SOUND, THE PHYSICIAN NEXT TRIED TO UNSCREW THE SETSCREW; HOWEVER, IT WAS SUCCESSFUL ONLY AT THE THIRD ATTEMPT (WITH THE SCREWDRIVER INSERTED PERPENDICULAR OR TILTED IN THE SCREWDRIVER SLOT). THE LEAD WAS FINALLY REMOVED FROM THE PORT. WHEN THE SCREWDRIVER WAS TAKEN OUT FROM THE PORT, THE SETSCREW WAS STUCK ON THE SCREWDRIVER. THE ICD WAS RETURNED FOR ANALYSIS. LEADS WERE CONNECTED TO A NEW ICD AND THE OPERATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN CRM S.R.L. PARADYM DR 8550 2632

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention