BEUDAMED
    FDA Adverse Event Summary report: N

    SPRINT

    MDR report key: 1862998 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-11380
    Date Received
    October 9, 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
    PA, 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 LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ANALYSIS RESULTS REVEALED HIGH RESISTANCE/IMPEDANCE MEASUREMENTS. THE DAILY HIGH VOLTAGE LEAD IMPEDANCE DATA SHOWS DEFIB ACTIVE CAN ON AND SUPERIOR VENA CAVA (SVC) DEFIB ABRUPTLY INCREASED WITH SVC DEFIB FROM 52 TO 254 OHMS BETWEEN (B)(6) 2010. THE DAILY PACE IMPEDANCE DATA SHOWS AN ABRUPT INCREASE FOR VENTRICULAR PACE BIPOLAR FROM 627 TO 1976 BETWEEN (B)(6) 2010. THERE WERE 2 PATIENT ALERTS FOR OUT OF TOLERANCE LEAD IMPEDANCE ON (B)(6) 2010. OVERSENSING WAS ALSO NOTED DURING ANALYSIS. THERE WERE 15 VENTRICULAR NON-SUSTAINED TACHYCARDIA EPISODES WITH INTERVALS OF LESS THAN OR EQUAL TO 210 MS ON (B)(6) 2010 IN A TIMEFRAME OF LESS THAN 15 MINUTES. IT WAS ALSO NOTED THAT LEAD INTEGRITY ALERT WAS TRIGGERED. THERE WAS 1 PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (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 DUE TO AN APPARENT LEAD FRACTURE, THE PATIENT GOT 3 SHOCKS AND THE HIGH VOLTAGE B ELECTRODE AND THE SUPERIOR VENA CAVA COIL IMPEDANCES WERE GREATER THAN 200 OHMS. OVERSENSING WAS NOTED WITH THE LEAD INTEGRITY ALERT BEING TRIPPED. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT ASKU LWS MEDTRONIC PUERTO RICO, INC. 6945 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4542 COMPETITIVE IMPLANTABLE PACING LEAD| 6940 IMPLANTABLE PACING LEAD| 6940 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4542 COMPETITIVE IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB