BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 1926151 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14199
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS REVEALED THAT THE LEAD INTEGRITY ALERT HAD TRIGGERED. THERE WAS ONE PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(6) 2010. ANALYSIS ALSO NOTED HIGH RESISTANCE/IMPEDANCE. THE DAILY PACE IMPEDANCE TREND DATA SHOWS AN ABRUPT INCREASE FOR VENTRICULAR PACE BI IMPEDANCE FROM 836 TO 4047 OHMS PEAK, THEN RETURNS TO 779 OHMS BETWEEN (B)(6) 2010 AND (B)(6) 2010. ANALYSIS ALSO OBSERVED THAT OVERSENSING WAS RECORDED. FIFTEEN VENTRICULAR NON-SUSTAINED TACHYCARDIAS WITH LESS THAN 210 MS AVERAGE VENTRICULAR CYCLE LENGTHS WERE RECORDED ON (B)(6) 2010 IN A TIMEFRAME OF JUST OVER AN HOUR. TWELVE VENTRICULAR FIBRILLATION EPISODES WITH AVERAGE CYCLE LENGTHS LESS THAN 210 MS WERE RECORDED BETWEEN (B)(6) 2009 AND (B)(6) 2010. ANALYSIS ADDITIONALLY IDENTIFIED THAT INTERFERENCE/NOISE WAS DETECTED. THE VENTRICULAR SHORT INTERVAL COUNT (V-SIC) AVERAGED 23.6 COUNTS/DAY, (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXPERIENCED NOISE, HAD AN INCREASE IN IMPEDANCE, AND DELIVERED INAPPROPRIATE SHOCKS DUE TO OVERSENSING. LEAD FRACTURE WAS SUSPECTED. THE LEAD WAS CAPPED 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB