BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2813197 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16253
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. HIGH RESISTANCE/IMPEDANCE WAS NOTED AS TWO PATIENT ALERT FOR RV PACE LEAD IMPEDANCE WAS > 2500 OHMS ON 08-SEP-2012 03:00:04 AND 12-SEP-2012 03:00:04. THE DAILY PACE LEAD IMPEDANCE LOG DATA SHOWS AN ABRUPT INCREASE FOR RV PACE FROM 472 TO 16382 OHMS PEAK BETWEEN 07-SEP-2012 AND 14-SEP-2012. OVERSENSING WAS NOTED AS EIGHT VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES AT <=210 MS OCCURRED ON 14-SEP-2012 IN THE TIMEFRAME BETWEEN 03:45:08 AND 06:58:53. SIX VENTRICULAR FIBRILLATION EPISODES AT 180 MS AVERAGE V-CYCLE OCCURRED BETWEEN 09-SEP-2012 09:05:13 AND 13-SEP-2012 00:42:05. INTERFERENCE/NOISE WAS NOTED AS VENTRICULAR SHORT INTERVAL COUNT WAS 2040.9 COUNTS AVG/DAY, IN 2.78 DAYS, BETWEEN 11-SEP-2012 14:29:21 AND 14-SEP-2012 08:04:19.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE THERAPIES. THE RIGHT VENTRICULAR LEAD HAD HIGH IMPEDANCE (AN OPEN CIRCUIT WAS NOTED), HAD EXIT BLOCK, AND WAS OVERSENSING. THE LEAD WAS EXPLANTED AND REPLACED. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R 7279 IMPLANTABLE PACEMAKER/CARDIO/DEFIB