BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2191008 · Received July 29, 2011

    Report

    Report Number
    1000165971-2011-00274
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 15, 2011
    Manufacturer
    SORIN CRM 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), 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 AN IMPLANT ATTEMPT OF THE SUBJECT DEVICE, CONNECTION ISSUES WERE REPORTED. LEAD MEASUREMENTS TAKEN DURING THE PROCEDURE WERE NORMAL; THESE LEADS WERE IMPLANTED ON (B)(6), 2002. THE PHYSICIAN INDICATED PROPER CONNECTION OF THE VENTRICULAR LEAD. HOWEVER, CLICKING OF THE SCREWDRIVER WAS NOT OBTAINED IN THE ATRIAL CHANNEL. THE PHYSICIAN LOOSENED THE SET-SCREW, AND UPON REMOVAL FROM THE PACEMAKER, THE SET-SCREW WAS ATTACHED TO THE TIP OF THE SCREWDRIVER. ANOTHER PACEMAKER WAS SUBSEQUENTLY IMPLANTED INSTEAD. IT WAS FURTHER REPORTED, THAT THE PHYSICIAN REINSERTED THE SET-SCREW INTO THE PACEMAKER HEADER, AND THAT IT IS NOT CERTAIN, IF THE PROPER SCREWDRIVER WILL BE RETURNED WITH THE DEVICE. THE RETURNED SCREWDRIVER COULD BE ASSOCIATED TO THE IMPLANTED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2518

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention