BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2964554 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02123
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 28, 2012
    Report Date
    February 8, 2018
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGEOUT WHILE WOUND CLOSURE WAS IN PROCESS, OVERSENSING DUE TO A POSSIBLE FRACTURE WAS OBSERVED ON THE PROGRAMMER SCREEN VIA DEVICE MARKERS. THE PHYSICIAN DECIDED TO EVALUATE THE DEVICE/LEAD CONNECTION AND THE MEASURED VALUES WERE WITHIN ACCEPTABLE LIMITS WHEN MEASURED WITH THE ANALYZER. THE LEAD WAS RECONNECTED TO THE DEVICE AND THE SENSITIVITY WAS REPROGRAMMED. THE LEAD REMAINS IN USE AND WILL BE EVALUATED AT THE PATIENT'S NEXT FOLLOW-UP VISIT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGEOUT WHILE WOUND CLOSURE WAS IN PROCESS, OVERSENSING DUE TO A POSSIBLE FRACTURE WAS OBSERVED ON THE PROGRAMMER SCREEN VIA DEVICE MARKERS. THE PHYSICIAN DECIDED TO EVALUATE THE DEVICE/LEAD CONNECTION AND THE MEASURED VALUES WERE WITHIN ACCEPTABLE LIMITS WHEN MEASURED WITH THE ANALYZER. THE LEAD WAS RECONNECTED TO THE DEVICE AND THE SENSITIVITY WAS REPROGRAMMED. IT WAS LATER REPORTED THAT THE PATIENT RETURNED TO THE HOSPITAL NOT FEELING WELL AND THE LEAD WAS EXHIBITING OVERSENSING. VENTRICULAR FIBRILLATION (VF) DETECTIONS WERE TURNED OFF AND THE PATIENT WAS TO BE MONITORED IN THE HOSPITAL. THE PATIENT CHECKED HERSELF OUT OF THE HOSPITAL THE NEXT DAY AGAINST MEDICAL ADVICE. THE LEAD REMAINS IN USE WITH VF DETECTIONS OFF. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS AND HIGH/UNDEFINED PACING IMPEDANCE. IT WAS NOTED THE HAD A HIGH NUMBER OF SHORT V-V INTERVALS. NOISE WAS ABLE TO BE REPRODUCED DURING ISOMETRIC EXERCISES. 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
    68664 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694465

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIAC DEFIBRILLATOR