BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN BIPOLAR OVER THE WIRE LEAD

    MDR report key: 2051499 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05572
    Event Type
    Injury
    Date Received
    April 12, 2011
    Report Date
    June 6, 2022
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    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 LEFT VENTRICULAR (LV) LEAD IS BEING USED AS THE PACE/SENSE CIRCUIT FOR THE RIGHT VENTRICLE (RV) AND T-WAVE OVERSENSING WAS OBSERVED. SENSITIVITY PARAMETERS WERE CHANGED AND IT WAS NOTED THAT THE PATIENT "FEELS GREAT". IT WAS LATER REPORTED THE LV LEAD CONTINUES TO HAVE T-WAVE OVERSENSING WITH SENSING INTEGRITY COUNTS (SIC) OF GREATER THAN 5000. REPROGRAMMED FROM DDDR TO DDIR TO AVOID INAPPROPRIATE RESPONSE TO THE SENSING CAUSING THE SIC INCREASE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONALLY, THE LV LEAD SHOWS POSSIBLE P-WAVE OVERSENSING. THE LV LEAD REMAINS IN USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD IS BEING USED AS THE PACE/SENSE CIRCUIT FOR THE RIGHT VENTRICLE (RV) AND T-WAVE OVERSENSING WAS OBSERVED. SENSITIVITY PARAMETERS WERE CHANGED AND IT WAS NOTED THAT THE PATIENT "FEELS GREAT". IT WAS LATER REPORTED THE LV LEAD CONTINUES TO HAVE T-WAVE OVERSENSING WITH SENSING INTEGRITY COUNTS (SIC) OF GREATER THAN 5000. REPROGRAMMED FROM DDDR TO DDIR TO AVOID INAPPROPRIATE RESPONSE TO THE SENSING CAUSING THE SIC INCREASE. IT WAS LATER REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM AFTER HEARING THE LEAD INTEGRITY ALERT DUE TO THE LV LEAD HAVING INTERMITTENT T-WAVE OVERSENSING. ADDITIONALLY, THE ATRIAL LEAD SHOWS POSSIBLE P-WAVE OVERSENSING. THE LV AND ATRIAL LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD IS BEING USED AS THE PACE/SENSE CIRCUIT FOR THE RIGHT VENTRICLE AND T-WAVE OVERSENSING WAS OBSERVED. SENSITIVITY PARAMETERS WERE CHANGED AND IT WAS NOTED THAT THE PATIENT "FEELS GREAT". NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN BIPOLAR OVER THE WIRE LEAD IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP MPRI 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD| 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD