BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCRA CRT-P

    MDR report key: 2953025 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00179
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 26, 2012
    Report Date
    February 6, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4) - THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. HOWEVER, THE DISTAL END OF THE ELECTRODE WAS COVERED INBLOOD. THERE WAS APPARENT EXPLANT DAMAGE. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. AT IMPLANT THE DEVICE CAN AND WILL TRY UNIPOLAR PACING. IT SHOULD DETECT THE BIPOLAR IMPEDANCE AND CONFIGURE TO BIPOLAR PACING BUT THERE MAY BE A PERIOD IN THE CASE YOU DESCRIBE WHERE THERE IS NOISE OR MAYBE THE SET SCREW HAS NOT BEEN SECURED, AND THE DEVICE COULD OVER-SENSE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEFT VENTRICULAR (LV) LEAD COULD NOT BE USED DUE TO PATIENT ANATOMY. A NEW LEAD WAS IMPLANTED. A NEW RIGHT VENTRICULAR (RV) LEAD WAS CONNECTED AND NOISE WAS OBSERVED AS WELL AS INTERMITTENT SENSING AND INAPPROPRIATE INHIBITION OF PACING CAUSING ASYSTOLE AFTER BEING CONNECTED TO THE NEW DEVICE. THE IMPEDANCE ALSO DECREASED. THE DEVICE WAS TAKEN OUT OF THE POCKET AND THE LEADS DISCONNECTED. MEASUREMENTS TAKEN ON ALL LEADS WERE CONSISTENT WITH VALUES AT IMPLANT EARLIER. IT WAS THOUGHT THAT THERE WAS A HEADER ISSUE WITH THE DEVICE. A NEW DEVICE WAS CONNECTED AND AGAIN, NOISE WAS SEEN ON THE RV LEAD. THE RV LEAD WAS THEN EXPLANTED AND A NEW LEAD REIMPLANTED IN THE RIGHT VENTRICLE. THE LEADS WERE CONNECTED TO THE NEW DEVICE AND ALL MEASUREMENTS WERE FUNCTIONING NORMALLY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56744 SYNCRA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND C2TR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| L| R