BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 1841908 · Received September 23, 2010

    Report

    Report Number
    2182208-2010-00630
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    September 6, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. EVALUATION SUMMARY: (B)(4) DISTAL CONDUCTOR FRACTURED; THE FULL LEAD IN SEGMENTS WAS RETURNED FOR ANALYSIS. THE LEAD WAS FLEXED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD HIGH IMPEDANCE AND HIGH THRESHOLD WITH NO CAPTURE. IT WAS ALSO REPORTED THAT THE CHILD HAS AN ABDOMINAL IMPLANT AND HAD A HISTORY OF BOUNDING OFF THE EDGE OF LOUNGE ON HER STOMACH AND JUMPING INTO THE EDGE OF THE LOUNGE ONTO HER STOMACH. IT WAS FURTHER REPORTED THAT WHEN SITTING ON A RELATIVES KNEE, HER EYES ROLLED BACK AND SHE FELL TO THE FLOOR (HER HEART RATE WAS REPORTED TO BE 25BPM). THE LEAD WAS EXPLANTED AND REPLACED. 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 EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4965 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention ADSR01 IMPLANTABLE PULSE GENERATOR