BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2373396 · Received December 14, 2011

    Report

    Report Number
    2649622-2011-18685
    Event Type
    Malfunction
    Date Received
    December 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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.

    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) PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED REVEALING HIGH RESISTANCE/IMPEDANCE WITH 2 - PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4) 2011 03:00:13 AND (B)(4) 2011 03:00:13. THE WEEKLY AND DAILY PACE LEAD IMPEDANCE TREND DATA SHOWED SPIKE INCREASES FOR MAX VENTRICULAR PACE BI IMPEDANCE = 532 TO 4047 OHMS RANGE BETWEEN (B)(4) 2011 AND (B)(4) 2011. THE LEAD INTEGRITY ALERT TRIGGERED WITH PROGRAMMER DATA SHOWING A LEAD INTEGRITY ALERT ON (B)(4) 2011 03:00:14.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PATIENT ALERT FOR THE RIGHT VENTRICULAR (RV) LEAD WHERE THERE IS A WIDELY VARIANT HIGH RV IMPEDANCE WITH THE HIGHEST VALUE OF 4047 OHMS. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PATIENT ALERT FOR THE RIGHT VENTRICULAR (RV) LEAD DUE TO A WIDELY VARIANT HIGH RV IMPEDANCE WITH THE HIGHEST VALUE OF 4047 OHMS. THE LEAD 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 67 YR Other 3093 MGU LEAD| 3023 MGU IPG| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 3023 MGU IPG| 3031A NEURO PROGRAMMER| 3095 NEURO EXTENSION| 3093 MGU LEAD| D224DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 3095 NEURO EXTENSION| 3031A NEURO PROGRAMMER| D224DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB