BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2791609 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14543
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING SEVERAL INAPPROPRIATE SHOCKS DUE TO OVERSENSING AND NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT STATED THAT THE DEVICE HAD BEEN BEEPING FOR A WEEK. IT WAS ALSO REPORTED THAT THE LEAD INTEGRITY ALERT (LIA) HAD TRIGGERED AND THE LEAD HAD HIGH IMPEDANCE AND WAS UNABLE TO CAPTURE. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT WAS TRANSFERRED TO A TERTIARY FACILITY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING SEVERAL INAPPROPRIATE SHOCKS DUE TO OVERSENSING AND NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT STATED THAT THE DEVICE HAD BEEN BEEPING FOR A WEEK. IT WAS ALSO REPORTED THAT THE LEAD INTEGRITY ALERT (LIA) HAD TRIGGERED AND THE LEAD HAD HIGH IMPEDANCE AND WAS UNABLE TO CAPTURE. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT WAS TRANSFERRED TO A TERTIARY FACILITY. IT WAS FURTHER REPORTED THAT THE LEAD WAS EXPLANTED DUE TO FRACTURE. THE PATIENT HAD A SUBCLAVIAN PERFORATION AND UNDERWENT AN OPEN CHEST REPAIR OF THE VEIN. THE LEAD WAS 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 SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R 4591 COMPETITOR IMPLANTABLE PACING LEAD| 4591 COMPETITOR IMPLANTABLE PACING LEAD| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4472 COMPETITOR IMPLANTABLE PACING LEAD| 4472 COMPETITOR IMPLANTABLE PACING LEAD