BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA CRT-D

    MDR report key: 2813506 · Received October 31, 2012

    Report

    Report Number
    2647346-2012-01771
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 2, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S171
    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. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND THERE WAS BLOOD ON THE TIP ELECTRODE. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET HEMATOMA. NO TREATMENT WAS REQUIRED AND THE DEVICE REMAINS IN USE. IT WAS ALSO REPORTED THAT AT PRE-DISCHARGE CHECK THE PACE/SENSE RIGHT VENTRICULAR (RV) LEAD HAD INTERMITTENT CAPTURE AND THE LEFT VENTRICULAR (LV) LEAD HAD NO CAPTURE. CHEST X-RAY CONFIRMED DISLODGEMENT OF BOTH LEADS. THE RV LEAD WAS REPOSITIONED INTO THE RV APEX AND REMAINS IN USE. REPOSITIONING OF THE LV LEAD WAS ATTEMPTED BUT NOT SUCCESSFUL. THE LV LEAD WAS EXPLANTED AND ANOTHER LV LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE NOTED 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 NIK MEDTRONIC MED REL, INC. D334TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O| R 4076 IMPLANTABLE PACING LEAD