BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2811943 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15898
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    August 2, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD DISLODGED AND HAD NO CAPTURE. THE LEAD WAS REPOSITIONED, BUT THE PATIENT DID NOT FOLLOW THE PHYSICIAN'S DIRECTIONS AND THE PATIENT REMOVED THE ARM OUT OF THE SLING WHICH CAUSED THE LEAD TO DISLODGE A SECOND TIME. THE LEAD WAS EXPLANTED AND WAS REPLACED WITH A NEW LEAD. 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 SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR| 4092 IMPLANTABLE PACING LEAD