BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 1992062 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02700
    Event Type
    Injury
    Date Received
    February 15, 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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4): PRELIMINARY TESTING REVEALED A NO OUTPUT CONDITION WHEN PROGRAMMED DDD VENTRICULAR BIPOLAR PACING AND ATRIAL UNIPOLAR PACING. NGT TESTING REVEALED ANOMALOUS OUTPUT CONDITIONS. THE NO OUTPUT CONDITION AT FUNCTIONAL TEST WAS THE RESULT OF LIFTED HYBRID BOND WIRES. LIFTS OCCURRED POST EXPLANT. ANALYSIS OF THE AUTOMATIC LEAD DIAGNOSTIC DATA FOUND THE VENTRICULAR LEAD MEASURED AN OPEN (B)(6) 2010 AND THE ATRIAL LEAD MEASURED AN OPEN ON (B)(6) 2010. THE EXPLANT DATE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4): PRELIMINARY TESTING REVEALED A NO OUTPUT CONDITION WHEN PROGRAMMED DDD VENTRICULAR BIPOLAR PACING AND ATRIAL UNIPOLAR PACING. NGT TESTING REVEALED ANOMALOUS OUTPUT CONDITIONS. THE NO OUTPUT CONDITION AT FUNCTIONAL TEST WAS THE RESULT OF LIFTED HYBRID BOND WIRES. LIFTS OCCURRED POST EXPLANT. ANALYSIS OF THE AUTOMATIC LEAD DIAGNOSTIC DATA FOUND THE VENTRICULAR LEAD MEASURED AN OPEN (B)(6) 2010 AND THE ATRIAL LEAD MEASURED AN OPEN ON (B)(6) 2010. THE EXPLANT DATE IS UNKNOWN. (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. HIGH ATRIAL IMPEDANCE/RESISTANCE AND ATRIAL LEAD RECORDED AS OPEN ON (B)(6) 2010. HIGH VENTRICULAR IMPEDANCE/RESIST AND VENTRICULAR LEAD RECORDED AS OPEN ON (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH LEADS THE VENTRICULAR AND ATRIAL LEADS SHOWED HIGH IMPEDANCE VALUES. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE WAS REPLACED DUE TO THE FIELD ADVISORY. THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH LEADS THE VENTRICULAR AND ATRIAL LEADS SHOWED HIGH IMPEDANCE VALUES. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS WERE 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 Hospitalization| O| R (B)(4) IMPLANTABLE PULSE GENERATOR