BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2291656 · Received October 13, 2011

    Report

    Report Number
    2649622-2011-15471
    Event Type
    Injury
    Date Received
    October 13, 2011
    Date of Event
    April 1, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. A 47 - VENTRICULAR NST <=210 MS BETWEEN (B)(4)-2011 15:20:04 AND (B)(4)-2011 07:55:13. VENTRICULAR SHORT INTERVAL COUNT V-SIC=204.3 COUNTS AVG/DAY, IN 103 DAYS, BETWEEN (B)(4)-2011 07:17:26 AND (B)(4)-2011 09:46:29. WEEKLY HV - LEAD MEASUREMENT LOG DATA SHOWS VARYING IMPEDANCE FOR MIN HV-CAN, MAX HV-COIL, MIN RING-COIL, AND MIN RING-CAN=51 TO 1.31 OHMS RANGE BETWEEN (B)(4)-2011. WEEKLY PACING LEAD IMPEDANCE TREND DATA SHOWS SPIKE DECREASES FOR MIN V.PACE = 610 TO 254 OHMS MINIMUM BETWEEN (B)(4)-2011.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING, SHOWED NOISE AND HAD DECREASING AND ODD CHANGES IN IMPEDANCE. THE LEAD WAS EXPLANTED AND REPLACED. 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 36 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB