BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 1861626 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-10008
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 6, 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
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED HIGH RESISTANCE/IMPEDANCE. OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE PATIENT ALERT WAS OBSERVED ON (B)(6) 2010. ALSO OVERSENSING WAS OBSERVED. ONE SHORT V-V CYCLE SENSED EVENT OF < 210 MS (NSVT) WAS OBSERVED ON (B)(6) 2010. AN ADDITIONAL EVENT WAS OBSERVED 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. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED HIGH RESISTANCE/IMPEDANCE. OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE PATIENT ALERT WAS OBSERVED ON (B)(6) 2010. ALSO OVERSENSING WAS OBSERVED. ONE SHORT V-V CYCLE SENSED EVENT OF < 210 MS (NSVT) WAS OBSERVED ON (B)(6)2010. AN ADDITIONAL EVENT WAS OBSERVED ON (B)(6)2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS OVERSENSING. IT WAS FURTHER QUESTIONED IF THE LEAD COULD BE FRACTURED. THE LEAD IS STILL IN USE. ADDITIONAL INFORMATION WAS RECEIVED AND THE RIGHT VENTRICULAR LEAD WAS DETECTING NOISE AND WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS OVERSENSING. IT WAS FURTHER QUESTIONED IF THE LEAD COULD BE FRACTURED. 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 86 YR Hospitalization| O| R 5072 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5072 IMPLANTABLE PACING LEAD