BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBQ

    MDR report key: 2810449 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15987
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. EVALUATION SUMMARY: (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA; 1 - PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012 09:00:04. PROGRAMMER PERFORMANCE DATA FILE (B)(4) SHOWS 1 - ALERT EVENT FOR "SVC DEFIB LEAD IMPEDANCE 170 OHMS" ON (B)(6) 2012 09:00:04.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD PACE/SENSE PORTION AND SUPRAVENTRICULAR COIL (SVC) PORTION OF THE LEADS HAD HIGH IMPEDANCE AND AN ALERT WAS TRIGGERED. A VENTRICULAR FIBRILLATION (VF) INDUCTION TEST WAS PERFORMED WITH NORMAL SHOCKING AND RE-CONVERSION. DUE TO THE CORRECT FUNCTIONING DURING INDUCTION TESTING, 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 PUERTO RICO, INC. 6996

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other D354VRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB