BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBQ

    MDR report key: 2456563 · Received February 16, 2012

    Report

    Report Number
    2182208-2012-00247
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Date of Event
    December 13, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IMPEDANCE - HIGH RESISTANCE/IMPEDANCE: 2 - PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6)-2011 09:00:12 AND (B)(6)-2011 03:00:12. PROGRAMMER S2D DATA SHOW ALERTS FOR LV PACING LEAD IMPEDANCE > 3000 OHMS ON (B)(6)-2011 09:00:12 AND (B)(6)-2011 03:00:12. IMPEDANCE - LOW RESISTANCE/IMPEDANCE: 1 - PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6)-2011 15:00:04. PROGRAMMER S2D DATA SHOWS AN ALERT FOR RV DEFIB LEAD IMPEDANCE= 19 OHMS ON (B)(6)-2011 15:00:04. IMPEDANCE - RESISTANCE/IMPEDANCE INCREASE: WEEKLY HV-LEAD IMPEDANCE TREND DATA SHOWS AN INCREASE FOR MAX DEFIB ACTIVE CAN ON AND MAX SVC DEFIB IMPEDANCE= 24 TO 110 OHMS PEAK BETWEEN (B)(6)-2011 AND (B)(6)-2011. SENSING - OVERSENSING: 1 - VF=190 MS AVERAGE V-CYCLE ON (B)(6)-2011 15:58:37. SENSING - HIGH RESISTANCE/IMPEDANCE: 1 - PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6)-2011 03:00:14. WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS A SPIKE INCREASE FOR MAX VENTRICULAR PACE BI IMPEDANCE = 798 TO 4047 OHMS PEAK BETWEEN (B)(6)-2011, THEN RETURNING TO A BASELINE OF 342 OHMS ON (B)(6)-2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD ALERT TRIGGERED, AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH IMPEDANCES. SHORTLY AFTER THAT, THE RIGHT VENTRICULAR (RV) AND SUPERIOR VENA CAVA (SVC) COILS EXHIBITED HIGH IMPEDANCES. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBQ IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6996

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other (B)(4) COMPETITOR IMPLANTABLE PACING LEADS| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD