BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2790197 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14712
    Event Type
    Injury
    Date Received
    October 15, 2012
    Report Date
    April 8, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES OF LESS THAN OR EQUAL TO 210 MS WERE RECORDED ON 2012-08-07. VENTRICULAR FIBRILLATION (VF) OF LESS THAN OR EQUAL TO 210 MS AVERAGE VENTRICULAR CYCLE WAS RECORDED ON (B)(6) 2012. (B)(4).

    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. SENSING - OVERSENSING 13 - VENTRICULAR NST<=210 MS ON (B)(6) 2012 IN THE TIMEFRAME BETWEEN 16:39:11 AND 16:58:49. 11 - VF<=210 MS AVERAGE V-CYCLE ON (B)(6) 2012 IN THE TIMEFRAME BETWEEN 16:11:21 AND 17:05:31. SENSING - INTERFERENCE/NOISE. VENTRICULAR SHORT INTERVAL COUNT V-SIC=1628.9 COUNTS AVG/DAY, IN 1.64 DAYS, BETWEEN (B)(6) 2012 20:22:19 AND (B)(6) 2012 11:40:52.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK. IT WAS ALSO REPORTED THAT RIGHT VENTRICULAR (RV) LEAD HAD NOISE. DURING THE LEAD REPLACEMENT SURGERY NO NOISE WAS FOUND ON THE RV LEAD. THE PHYSICIAN SUSPECTED A CONNECTOR ISSUE WITH THE DEVICE AND THE DEVICE WAS REPLACED. AFTER THE DEVICE REPLACEMENT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO NOISE AND THE RV LEAD WAS ALSO 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R