BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2790577 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15347
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    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.

    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. A RESISTANCE/IMPEDANCE INCREASE WAS NOTED WITH WEEKLY PACE LEAD IMPEDANCE TREND DATA SHOW VARIOUS SPIKE INCREASES FOR MINIMUM AND MAXIMUM RIGHT VENTRICULAR (RV) PACE EQUAL TO 376 TO 816 OHMS RANGE BETWEEN (B)(6) 2011 AND (B)(6) 2012. A LEAD INTEGRITY ALERT TRIGGERED AND THE PROGRAMMER DATA SHOWED FIVE RV LEAD INTEGRITY ALERTS BETWEEN (B)(6) 2012. THERE WERE FIVE PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE BETWEEN (B)(6) 2012. OVERSENSING WAS NOTED WITH TWO VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES LESS THAN OR EQUAL TO 210 MS ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME IN FOR A FOLLOW UP VISIT BECAUSE THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT. UPON INTERROGATION AND TESTING, THE PHYSICIAN NOTED OVERSENSING AND THAT THE LEAD DELIVERED INADEQUATE THERAPY DURING TWO INDUCTED SHOCKS ON THE VENTRICULAR TACHYCARDIA EPISODES. AN RV LEAD FRACTURE WAS SUSPECTED. A REVIEW OF THE PRODUCT PERFORMANCE INFORMATION FOUND THAT BOTH THE RV AND RA (RIGHT ATRIAL) LEADS HAD VARIABLE IMPEDANCE. BOTH LEADS REMAIN IN USE BUT A REVISION OF THE RV LEAD IS EXPECTED. 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 56 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB