BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 2130947 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10315
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 1, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. EVALUATION SUMMARY : (B)(4): THE DEVICE WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND.

    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 DEVICE WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND.

    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 DEVICE WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER TWO SYNCOPAL EPISODES AND A LOW HEART RATE. THE DEVICE WAS NOT CAPTURING THE VENTRICLE AND THE RIGHT VENTRICULAR LEAD HAD HIGH THRESHOLDS. THE DEVICE WAS EXPLANTED AND REPLACED AND THE LEAD WAS INACTIVATED AND NEW LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT INJURED THE RIGHT SHOULDER DURING THE SECOND SYNCOPAL EPISODE. IT WAS ALSO CLARIFIED THAT THE LEAD WAS CAPPED. IT WAS LATER NOTED THAT THE RIGHT VENTRICULAR LEAD DID NOT HAVE HIGH THRESHOLDS; THE THRESHOLD MEASUREMENTS WERE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER TWO SYNCOPAL EPISODES AND A LOW HEART RATE. THE DEVICE WAS NOT CAPTURING THE VENTRICLE AND THE RIGHT VENTRICULAR LEAD HAD HIGH THRESHOLDS. THE DEVICE WAS EXPLANTED AND REPLACED AND THE LEAD WAS INACTIVATED AND NEW LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT INJURED THE RIGHT SHOULDER DURING THE SECOND SYNCOPAL EPISODE. IT WAS ALSO CLARIFIED THAT THE LEAD WAS CAPPED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER TWO SYNCOPAL EPISODES AND A LOW HEART RATE. THE DEVICE WAS NOT CAPTURING THE VENTRICLE AND THE RIGHT VENTRICULAR LEAD HAD HIGH THRESHOLDS. THE DEVICE WAS EXPLANTED AND REPLACED AND THE LEAD WAS INACTIVATED AND NEW LEAD WAS IMPLANTED. 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 CAPSURE SENSE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4074 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R 4574 IMPLANTABLE PACING LEAD| 4574 IMPLANTABLE PACING LEAD| 4574 IMPLANTABLE PACING LEAD