BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW-IN

    MDR report key: 2791557 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15446
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    May 3, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 AND ANALYZED. THE HELIX/LOBE WAS DISTORTED/BENT, AND THE LEAD APPEARED TO HAVE BEEN DAMAGED AT IMPLANT. (B)(4) - THE FULL LEAD WAS RETURNED IN SEGMENTS AND WAS ANALYZED. NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS FOUND ON ALL CONDUCTORS, INCLUDING THE DISTAL CONDUCTOR (NOT OBSTRUCTED).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR [LV] LEAD DISLODGED WHICH RESULTED IN HIGH THRESHOLD MEASUREMENTS. IT WAS ALSO REPORTED THAT DURING THE PROCEDURE TO REPLACE THE DISLODGED LEAD, THE HELIX OF THE REPLACEMENT LEAD WAS "SEVERELY" BENT PRIOR TO IMPLANT WHEN THE PHYSICIAN ATTEMPTED TO EXTEND THE HELIX WITH A PAIR OF METAL FORCEPS. THE DISLODGED LV LEAD WAS REMOVED AND A SECOND REPLACEMENT LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW-IN IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5071

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R D314TRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD