BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2131850 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10573
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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)(6) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. SENSING - OVERSENSING 1 - VENTRICULAR NST=200 MS AVERAGE V-CYCLE ON (B)(6) 2011 06:23:43. 1 - VF=160 MS ON (B)(6) 2011 AT 16:50:07. SENSING - INTERFERENCE/NOISE VENTRICULAR SHORT INTERVAL COUNT V-SIC=25.9 COUNTS AVG/DAY, IN 50.7 DAYS, BETWEEN (B)(6) 2011 17:12:20 AND (B)(6) 2011 09:36:14.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED OVERSENSING. DURING LEAD REVISION PROCEDURE, IT WAS NOTED THAT THE PIN WAS IN THE CONNECTOR BLOCK AT AN ANGLE, AND OVERSENSING WAS NOTED WHILE MANIPULATING THE PORTION OF THE LEAD DISTAL TO THE CONNECTOR BLOCK. THE LEAD WAS REINSERTED WITHOUT ADDITIONAL OVERSENSING, AND REMAINS 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 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB