BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCRA CRT-P

    MDR report key: 2811606 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02548
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    May 10, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P010015/S084
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH LEFT VENTRICULAR THRESHOLDS WERE NOTED APPROXIMATELY FOUR MONTHS AFTER IMPLANT. DURING THE LEAD REVISION PROCEDURE, THE DEVICE LONGEVITY WAS NOTED TO SHOWED AN UNEXPECTED LONGEVITY OF 12 MONTHS REMAINING. THE PHYSICIAN WAS UNWILLING TO RISK ANOTHER SURGERY THAT SOON, SO THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF TH IS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH LEFT VENTRICULAR THRESHOLDS WERE NOTED APPROXIMATELY FOUR MONTHS AFTER IMPLANT. DURING THE LEAD REVISION PROCEDURE, THE DEVICE LONGEVITY WAS NOTED TO SHOWED AN UNEXPECTED LONGEVITY OF 12 MONTHS REMAINING. THE PHYSICIAN WAS UNWILLING TO RISK ANOTHER SURGERY THAT SOON, SO THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Other