BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1922401 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05939
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 1, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IMPEDANCE - VARYING RESISTANCE/IMPEDANCE. WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS MAX RV PACE IMPEDANCE VARYING FOR MAX RV PACE= 536 TO 872 OHMS PEAK BETWEEN (B)(6) 2010 TO (B)(6) 2010. (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. (B)(4) - NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT VENTRICULAR (LV) 4193 LEAD WAS CAUSING DIAPHRAMATIC STIMULATION. IN ADDITION, UPON CHECKING THE PATIENT'S DEVICE, NO RIGHT VENTRICULAR (RV) CAPTURE, POOR SENSING AND VARYING/HIGH IMPEDANCE WAS NOTED ON THE EXISTING 6947 LEAD. THE DECISION WAS MADE TO ADD A NEW 6947 LEAD AND AN EPICARDIAL LEAD. DURING THE IMPLANT PROCEDURE, THERE WAS DIFFICULTY POSITIONING THE NEW 6947 LEAD AND DIFFICULTY VERIFYING THE LEAD TIP HELIX EXTENTION/RETRACTION. THE LEAD WAS REMOVED AND EVENTUALLY ABLE TO EXTEND ON THE TABLE AFTER 30 TURNS. IN AN ATTEMPT TO PLACE ANOTHER NEW LEAD, IT WAS NOTED THAT THE SHEATH WAS IN THE RIGHT VENTRICULAR APEX. SIGNIFICANT BLEEDING FROM PERFORATION OF THE RV WAS OBSERVED AND WAS EVENTUALLY STOPPED. THE OLD 4193 AND 6947 LEADS WERE CAPPED. THE SVC SET SCREW FOR THE DEVICE WAS UNABLE TO BE TIGHTENED SO A NEW DEVICE WAS USED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT VENTRICULAR (LV) (B)(4) LEAD WAS CAUSING DIAPHRAGMATIC STIMULATION. IN ADDITION, UPON CHECKING THE PATIENT'S DEVICE, NO RIGHT VENTRICULAR (RV) CAPTURE, POOR SENSING AND VARYING/HIGH IMPEDANCE WAS NOTED ON THE EXISTING (B)(4) LEAD. THE DECISION WAS MADE TO ADD A NEW (B)(4) LEAD AND AN EPICARDIAL LEAD. DURING THE IMPLANT PROCEDURE, THERE WAS DIFFICULTY POSITIONING THE NEW (B)(4) LEAD WITH NO CAPTURE, HIGH THRESHOLDS, HIGH RESISTANCE, AND DIFFICULTY WITH HELIX EXTENSION/RETRACTION. THE LEAD WAS REMOVED AND EVENTUALLY ABLE TO EXTEND ON THE TABLE AFTER 30 TURNS. IN AN ATTEMPT TO PLACE ANOTHER NEW LEAD, IT WAS NOTED THAT THE SHEATH WAS IN THE RIGHT VENTRICULAR APEX. SIGNIFICANT BLEEDING FROM PERFORATION OF THE RV WAS OBSERVED AND WAS EVENTUALLY STOPPED. THE OLD (B)(4) AND (B)(4) LEADS WERE CAPPED. THE SVC SET SCREW FOR THE DEVICE WAS UNABLE TO BE TIGHTENED SO A NEW DEVICE WAS USED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO CRT-D DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. C154DWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD