BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2934536 · Received January 28, 2013

    Report

    Report Number
    1000165971-2013-00042
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 15, 2013
    Manufacturer
    SORIN C.R.M., S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING AN IMPLANT ATTEMPT ELECTRICAL AND CONNECTION ISSUES WERE REPORTED TO THE SUBJECT PACEMAKER. REPORTEDLY THE PATIENT SHOWED 3:1 AV BLOCK AND SPONTANEOUS RHYTHM AROUND 40BPM BEFORE THE IMPLANTATION. DURING THE INTERVENTION, BEFORE CONNECTING THE LEADS, SPONTANEOUS RHYTHM WAS CHECKED, HOWEVER VENTRICULAR RHYTHM DID NOT APPEAR EVEN WITH A PACING RATE OF 30 MIN-1. WHEN THE VENTRICULAR LEAD WAS INSERTED INTO THE DEVICE TRANSIENT COMPLETE AV BLOCK WAS OBSERVED. THE LEAD WAS THEN CONNECTED TO THE EXTERNAL PACEMAKER AND PACING WAS DELIVERED. SUBSEQUENTLY THE ATRIAL LEAD WAS INSERTED. AFTER INSERTING THE SCREWDRIVER INTO THE ASSOCIATED SLOT, THE VENTRICULAR LEAD WAS RECONNECTED TO THE SUBJECT DEVICE: THE CONNECTOR PIN WAS PROTRUDED FROM THE CONNECTOR BLOCK BUT CLICK SOUND WAS NOT HEARD WHEN THE PHYSICIAN TURNED THE SCREWDRIVER AND PACING SPIKES WERE NOT CONFIRMED. THE LEAD WAS SUBSEQUENTLY PULLED EASILY FROM THE DEVICE WITHOUT UNSCREWING THE SET-SCREW AND RECONNECTED TO THE EXTERNAL PACEMAKER. CARDIAC ARREST WAS CONFIRMED FOR 10 SECONDS. THE LEAD WAS THEN RE-CONNECTED TO THE SUBJECT DEVICE WITH THE SCREWDRIVER FULLY INSERTED INTO THE SLOT AND CLICK SOUND AS CONFIRMED, HOWEVER PACING FAILURE AND CARDIAC ARREST WERE OBSERVED AGAIN. A NEW DEVICE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37791 REPLY NVZ SORIN C.R.M., S.R.L. REPLY DR 2646

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention