BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2207635 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-13485
    Event Type
    Injury
    Date Received
    August 11, 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
    AU
    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 DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. STD REVIEW - LEAD INTEGRITY ALERT TRIGGERED PROGRAMMER DATA SHOWS A LEAD INTEGRITY ALERT ON (B)(6) 2011 16:51:56.1 - PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2011 16:51:56. IMPEDANCE - HIGH RESISTANCE/IMPEDANCE 2 - PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2011 02:15:03 AND (B)(6) 2011 02:15:05. DAILY PACE IMPEDANCE TREND DATA SHOWS AN ABRUPT INCREASE FOR RV PACE= 560 TO INF OHMS (UNFILTERED) PEAK BETWEEN (B)(6) 2011. SENSING - OVERSENSING 14 - VENTRICULAR NST<=210 MS AVERAGE V-CYCLE ON (B)(6) 2011 IN THE TIMEFRAME BETWEEN 05:35:14 AND 07:14:40. 5 - VF<=190 MS AVERAGE V-CYCLE ON (B)(6) 2011 IN THE TIMEFRAME BETWEEN 01:11:08 AND 04:06:47. SENSING - INTERFERENCE/NOISE VENTRICULAR SHORT INTERVAL COUNT V-SIC=3433.5 COUNTS AVG/DAY, IN 1.30 DAYS, BETWEEN (B)(6) 2011 07:19:08 AND (B)(6) 2011 14:36:22. VENTRICULAR SHORT INTERVAL COUNT V-SIC=2305 COUNTS, IN 0.60 DAY, BETWEEN (B)(6) 2011 16:48:55 AND (B)(6) 2011 07:15:59.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED 5 INAPPROPRIATE SHOCKS AS THE RIGHT VENTRICULAR LEAD HAD NOISE, OVERSENSING, HIGH IMPEDANCE, NO CAPTURE, AND A FRACTURE. IT WAS ALSO REPORTED THAT THE DEVICE WAS REPROGRAMMED TO TURN OFF THERAPIES. THE LEAD WAS LATER CUT, CAPPED AND REPLACED WITH A NEW LEAD. NO FURTHER 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 54 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB