BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2230563 · Received August 12, 2011

    Report

    Report Number
    1000165971-2011-00293
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 3, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING THE IMPLANT PROCEDURE RELATIVE TO THE SUBJECT DEVICE VENTRICULAR CONNECTION ISSUES WERE REPORTED, SINCE A CLICKING SOUND WAS NOT OBTAINED IN THE VENTRICULAR CHANNEL. A LEAD PULL TEST WAS PERFORMED AND THE LEAD REMAINED INSIDE THE CHANNEL. THE PHYSICIAN RE-INSERTED THE SCREWDRIVER PERPENDICULARLY AND WAS ABLE TO OBTAIN THE CLICK SOUND. ANOTHER PULL TEST INDICATED PROPER CONNECTION. THE SALES REP REPORTED THAT AT THAT TIME ONLY ATRIAL SPIKES WERE VISIBLE ON THE ECG, HOWEVER IN THE END ALSO VENTRICULAR SPIKES BECAME VISIBLE INTERMITTENTLY. A MAGNET WAS PLACED OVER THE PACEMAKER BEFORE CLOSING THE POCKET RESULTING IN APPROPRIATE ATRIAL AND VENTRICULAR PACING AT A RATE OF 96 PPM. BECAUSE OF INTERMITTENT POCKET STIMULATION, IT WAS DECIDED TO PROGRAM (AFTER CLOSING OF THE POCKET) THE LEAD CONFIGURATION TO BIPOLAR BOTH FOR SENSING AND PACING. DURING THE FOLLOW-UP IMMEDIATELY AFTER IMPLANT VENTRICULAR LEAD PROBLEMS WERE INDICATED (NOT ABLE TO PROGRAM IN BIPOLAR, INTERMITTENT HIGH LEAD IMPEDANCE MEASUREMENTS). HOWEVER, THE SENSING AND PACING VALUES WERE COMPARABLE TO THE VALUES AS MEASURED DURING IMPLANT. X-RAY IMAGING WAS PERFORMED WHICH INDICATED THAT THE IS-1 VENTRICULAR LEAD PIN DID "COME OUT OF" THE PROXIMAL CONNECTOR BLOCK. A REINTERVENTION WAS PERFORMED AND THE VENTRICULAR LEAD CONNECTOR COULD BE REMOVED WITHOUT UNSCREWING THE SET SCREW. A RECONNECTION ATTEMPT WAS MADE YIELDING CONNECTION PROBLEMS (LEAD EASILY REMOVED). THE PHYSICIAN LOOSENED THE SET-SCREW WITH MANY TURNS, AND WAS SUBSEQUENTLY ABLE TO PROPERLY CONNECT THE LEAD. THE SUBJECT DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2516

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention