BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADYM

    MDR report key: 2792240 · Received October 12, 2012

    Report

    Report Number
    1000165971-2012-00377
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 21, 2012
    Manufacturer
    SORIN C.R.M., S.R.L.
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE IMPLANTATION PROCEDURE OF THE SUBJECT ICD, A CONNECTION ISSUE OCCURRED WITH THE (RV) DF-1 CONNECTOR. THE PHYSICIAN NOTICED THAT WHEN SHE TRIED TO TIGHT, THE SETSCREW DIDN'T MADE THE CLICK SOUND AND THE SETSCREW DIDN'T OFFER ANY RESISTANCE WHEN TURNING CLOCKWISE TO FIX THE LEAD, IT FEELS LIKE THE SETSCREW WAS FREE. HOWEVER, THE DISTAL PART OF THE (RV) DF-1 LEAD WAS CONNECTED/FIXED TO THE ICD CONNECTOR AND IT WAS NOT POSSIBLE TO REMOVE WITHOUT THE SCREWDRIVER. THE PHYSICIAN TRIED TO LOOSEN THE SETSCREW AND REMOVE THE DISTAL PART OF THE LEAD (RV) DF-1 AND HAD DIFFICULT TO REMOVE IT FROM THE ICD CONNECTOR EVEN WITH A NEW SCREWDRIVER. FINALLY THE LEAD TIP COULD HAVE BEEN REMOVED BUT WITH DIFFICULTIES. THE PHYSICIAN TRIED AGAIN TO CONNECT THE (RV) DF-1 LEAD TIP BUT SHE MET THE SAME DIFFICULTIES. FINALLY THE DEVICE WAS NOT IMPLANTED AND RETURNED FOR ANALYSIS. ANOTHER DEVICE WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADYM MRM SORIN C.R.M., S.R.L. PARADYM RF VR 9250 2602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention