BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 1791079 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-07021
    Event Type
    Injury
    Date Received
    August 10, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IMPEDANCE TRENDS STEADY. THE LIFETIME VENTRICULAR SENSING INTEGRITY COUNTER IS 2394 AND ALL COUNTS OCCURRED SINCE (B)(6) 2009. A HIGH VALUE OF THIS COUNT CAN INDICATE A POSSIBLE INTERMITTENCY IN THE SYSTEM. (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. 1 - PATIENT ALERT RV. PACE LEAD Z<200 OHMS ON (B)(6) 2011. WEEKLY PACING MEASUREMENT LOG DATA SHOWS A GRADUAL DECREASE FOR MAX AND MIN V.PACE=252 TO 196 OHMS MINIMUM BETWEEN (B)(6) 2010 AND (B)(6) 2011. 35 - VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA) <=210 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2011 14:49:05 AND (B)(6) 2011 08:45:31. 1 - VF=190 MS ON (B)(6) 2009 21:56:59. VENTRICULAR SHORT INTERVAL COUNT V-SIC=30.7 COUNTS AVG/DAY, IN (B)(6), BETWEEN (B)(6) 2010 23:09:35 AND (B)(6) 2011 12:23:54.

    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): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IMPEDANCE TRENDS STEADY. THE LIFETIME VENTRICULAR SENSING INTEGRITY COUNTER IS 2394 AND ALL COUNTS OCCURRED SINCE (B)(6) 2009. A HIGH VALUE OF THIS COUNT CAN INDICATE A POSSIBLE INTERMITTENCY IN THE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SHORT INTERVAL COUNT WAS INCREASING, INDICATING POSSIBLE OVERSENSING, AND THE PATIENT WAS SHOCKED MULTIPLE TIMES. THE DEVICE AND LEAD ARE STILL IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SHORT INTERVAL COUNT WAS INCREASING, INDICATING POSSIBLE OVERSENSING, AND THE PATIENT WAS SHOCKED MULTIPLE TIMES. THE DEVICE AND LEAD ARE STILL IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. FURTHER INFORMATION NOTED THAT THE LEAD INTEGRITY ALERT TRIGGERED DUE TO OVERSENSING AND LOW IMPEDANCE. UPON EXPLANT, IT WAS FOUND THAT THE LEAD HAD INSULATION THAT WAS CUT AND WORN. THE LEAD COULD NOT BE EXTRACTED. THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6943 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| O| R