BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCRA CRT-P

    MDR report key: 3153643 · Received June 8, 2013

    Report

    Report Number
    9614453-2013-01152
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    April 4, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT IMPLANT DETECT APPEARS TO HAVE BEEN COMPLETED MANUALLY.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL PORT WAS PLUGGED AND IMPLANT DETECT DID NOT COMPLETE. AS A RESULT, THE DEVICE IS SUSCEPTIBLE TO OVERSENSING AND DIAGNOSTIC FEATURES DID NOT WORK AS DESIGNED. ATRIAL SENSITIVITY WAS REPROGRAMMED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255948 SYNCRA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND C2TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 4296 IMPLANTABLE PACING LEAD