BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 1921274 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12429
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 1, 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
    TX, 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.

    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. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED "VARYING RESISTANCE/IMPEDANCE". DAILY - HV LEAD IMPEDANCE TREND DATA SHOWS DEFIB ACTIVE CAN ON IMPEDANCE AND SVC DEFIB VARYING FROM A BASELINE OF SVC DEFIB=41 TO A PEAK OF 254 OHMS BETWEEN (B)(6) 2010. THE ANALYSIS ALSO REVEALED "HIGH RESISTANCE/IMPEDANCE". 2 - PATIENT ALERTS FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2010 21:00:07 AND (B)(6) 2010 03:00:14.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-IMPLANT HIGH-VOLTAGE LEAD IMPEDANCE ALERTS OCCURRED AND THE HIGH VOLTAGE LEAD IMPEDANCE MEASURED HIGH. THE PATIENT WAS RETURNED TO SURGERY AND A LEAD CONNECTOR PIN PLUG ISSUE WAS NOTED AND CORRECTION WAS ATTEMPTED. IT WAS SUBSEQUENTLY REPORTED POST-REVISION, THAT THE LEAD CONTINUED TO EXHIBIT HIGH AND VARYING IMPEDANCE, WITH RECORDED NON-SUSTAINED TACHYCARDIA EPISODES INDICATING THE POSSIBILITY OF OVERSENSING. THE LEAD IS STILL IN USE. 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 QUATTRO IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD| 6940 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| 6940 IMPLANTABLE PACING LEAD