BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2200571 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01092
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    March 18, 2011
    Report Date
    May 1, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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, ANALYZED AND NO ANOMALIES WERE 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, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED INAPPROPRIATE SENSING AND WAS CONSIDERED 'FAULTY.' THE LEAD WAS CAPPED AND REPLACED. IT WAS ALSO REPORTED THAT THE DEVICE HAD A SUSPECTED FAILURE AND WAS SENSING INAPPROPRIATELY DUE TO THE LEAD. IT WAS FURTHER REPORTED THAT THE LEAD WAS SLIDING AROUND IN THE PERICARDIUM AND RUBBING ON ANOTHER LEAD CAUSING OVERSENSING. IT WAS NOT KNOWN IF THERE WAS AN ISSUE WITH THE HEADER AS IT COULD NOT BE REPRODUCED, SO IT WAS DECIDED THAT BOTH THE DEVICE AND THE LEAD WOULD BE CHANGED OUT. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED INAPPROPRIATE SENSING AND WAS CONSIDERED 'FAULTY.' THE LEAD WAS CAPPED AND REPLACED. IT WAS ALSO REPORTED THAT THE DEVICE HAD A SUSPECTED FAILURE WAS SENSING INAPPROPRIATELY DUE TO THE LEAD. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4968 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O| R 6937A IMPLANTABLE TACHY LEAD| 6937A IMPLANTABLE TACHY LEAD| 6996 IMPLANTABLE TACHY LEAD| 6996 IMPLANTABLE TACHY LEAD