BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA CRT-D

    MDR report key: 2790785 · Received October 15, 2012

    Report

    Report Number
    6000094-2012-02269
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 4, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. EVALUATION SUMMARY: (B)(4) - THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. PERFORMANCE DATA FROM THE DEVICE WAS ANALYZED AND REVEALED THAT THERE WERE 7 PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE. THE FILE SHOWS 7 ALERT EVENTS FRO "LVTIP TO RVCOIL LEAD IMPEDANCE > 3000 OHMS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A COUPLE WEEKS AFTER IMPLANT OF THE DEVICE, THE LEFT VENTRICULAR (LV) IMPEDANCE WAS GREATER THAN 3000 OHMS. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL AND AN ATTEMPT WAS MADE TO TIGHTEN THE DEVICE'S LV SETSCREW. THE LV IMPEDANCE WAS VARYING FROM ZERO OHMS, TO 740 OHMS AND THEN TO GREATER THAN 3000 OHMS, AND THERE WAS NO CAPTURE. ONCE IT WAS DETERMINED THAT THE LV LEAD WAS OK, THE DEVICE WAS REMOVED 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 PROTECTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. D364TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNKNOWN IMPLANTABLE PACING LEAD| 5071 IMPLANTABLE PACING LEAD| UNKNOWN IMPLANTABLE PACING LEAD