BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2131135 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10403
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S15
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED OVERSENSING.

    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. CORRECTION: EVALUATION SUMMARY: (B)(4) AND (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED OVERSENSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC POST HOLTER SCAN REPORTING SYMPTOMS OF INTERMITTENT DIZZINESS AND SKIPPED BEATS. IT WAS ALSO REPORTED THAT THE DEVICE INTERROGATION SHOWED INTERMITTENT VENTRICULAR PACING, INTERMITTENT VENTRICULAR OVERSENSING, NO R WAVES AT VVI 30 BEATS PER MINUTE AND AN UNDERLYING RHYTHM OF COMPLETE HEART BLOCK. THE DEVICE WAS REPROGRAMMED AND THE DEVICE AND LEAD REMAIN IN USE. THE PATIENT WAS REFERRED TO CARDIAC SURGERY AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC POST HOLTER SCAN REPORTING SYMPTOMS OF INTERMITTENT DIZZINESS AND SKIPPED BEATS. IT WAS ALSO REPORTED THAT THE DEVICE INTERROGATION SHOWED INTERMITTENT VENTRICULAR PACING, INTERMITTENT VENTRICULAR OVERSENSING, NO R WAVES AT VVI 30 BEATS PER MINUTE AND AN UNDERLYING RHYTHM OF COMPLETE HEART BLOCK. THE DEVICE WAS REPROGRAMMED AND THE DEVICE AND LEAD REMAIN IN USE. THE PATIENT WAS REFERRED TO CARDIAC SURGERY AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5024M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R