BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY STEERABLE

    MDR report key: 2165430 · Received July 17, 2011

    Report

    Report Number
    2124215-2011-08200
    Event Type
    Injury
    Date Received
    July 17, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 4, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVY
    PMA / PMN Number
    P050046/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION IS EXPECTED, THIS INVESTIGATION IS COMPLETE. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT A REVISION PROCEDURE WAS PERFORMED. PREVIOUS OBSERVATIONS OF INCREASED THRESHOLD MEASUREMENTS AND IMPEDANCE MEASUREMENTS GREATER THAN 2,000 INDICATED LA IKELY MICRO-FRACTURE TO HAVE OCCURRED. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED WITHOUT COMPLICATION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LEFT VENTRICULAR (LV) IMPEDANCE MEASUREMENT GREATER THAN 2,000 OHMS WAS OBSERVED. THE PATIENT IMPLANTED WITH THIS DEVICE SYSTEM WAS BROUGHT INTO THE CLINIC FOR FURTHER EVALUATION. LOSS OF CAPTURE (LOC) WAS OBSERVED AT MAXIMUM OUTPUT IN THE RING TO COIL CONFIGURATION. FURTHER TESTING IN THE TIP TO COIL CONFIGURATION RESULTED IN GREATER THAN 2,000 OHMS IMPEDANCES, HOWEVER, CAPTURE WAS OBSERVED AT 4.0 VOLTS. ADDITIONALLY, PACING THRESHOLD MEASUREMENTS HAD INCREASED TO 3.5 VOLTS IN THE TIP TO COIL CONFIGURATION. POCKET MANIPULATION AND ISOMETRIC TESTING WAS UNSUCCESSFUL IN CREATING NOISE. TECHNICAL SERVICES DISCUSSED PERFORMING AN XRAY. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE WAS TO DISCUSS WITH THE PATIENT'S PHYSICIAN AND PLANNED TO REPROGRAM THE DEVICE CONFIGURATION TIP TO COIL TO ALLOW FOR CAPTURE. AN XRAY WAS PERFORMED, WHICH CONFIRMED THAT THE LV LEAD HAD DISLODGED. A REVISION PROCEDURE HAD NOT YET BEEN SCHEDULED. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS LEFT VENTRICULAR LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS. UPON FURTHER EVALUATION THIS LEAD WAS ALSO FOUND TO BE DISLODGED, EXHIBITED HIGH THRESHOLDS AND LOSS OF CAPTURE DUE TO A SUSPECTED FRACTURE. THIS LEAD WAS THEN SURGICALLY ABANDONED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD AS ATTEMPTED TO BE DISTRACTED, BUT WAS UNABLE TO AS THE LEAD BROKE DUE TO A CONDUCTOR FRACTURE. THIS LEAD WAS ONCE AGAIN SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY STEERABLE IMPLANTABLE LEAD NVY BOSTON SCIENTIFIC CORPORATION 4555 161622

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R 0175| 4555| 4136| H210