BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2812569 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17178
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    November 28, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA HAS BEEN COLLECTED FROM THE DEVICE AND HAS BEEN ANALYZED. SENSING/OVERSENSING: 5 - VENTRICULAR NST <(><<)>=210 MS ON (B)(6) 2012 IN THE TIMEFRAME BETWEEN 09:40:51 AND 10:10:53. VENTRICULAR SHORT INTERVAL COUNT V-SIC=5521 COUNTS, IN 7.67 DAYS, BETWEEN (B)(6) 2012 19:09:09 AND (B)(6) 2012 11:13:59. IMPEDANCE/HIGH IMPEDANCE: 1 - PATIENT ALERT FOR OOT SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012 03:00:08. WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOWS AN ABRUPT INCREASE FOR MIN AND MAX VENTRICULAR PACE BI = 437 TO 1254OHMS PEAK BETWEEN (B)(6) 2012. ALERTS: 1 - PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012 09:43:35.

    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 A RIGHT VENTRICULAR [RV] LEAD FRACTURE WAS SUSPECTED. IT WAS ALSO REPORTED THAT THERE WERE ELEVATED AND HIGH I MPEDANCE MEASUREMENTS, A HIGH SENSING INTEGRITY COUNT [SIC], NOISE WAS PRESENT AND A LEAD INTEGRITY ALERT [LIA] WAS TRIGGERED. THE RV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RIGHT VENTRICULAR [RV] LEAD FRACTURE WAS SUSPECTED. IT WAS ALSO REPORTED THAT THERE WERE ELEVATED AND HIGH IMPEDANCE MEASUREMENTS, A HIGH SENSING INTEGRITY COUNT [SIC], NOISE WAS PRESENT AND A LEAD INTEGRITY ALERT [LIA] WAS TRIGGERED. THE RV 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 S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD