BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1072200 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03884
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    April 16, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: NO ANOMALIES FOUND; FULL LEAD RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE UNACCEPTABLE THRESHOLDS AND THAT THE LEAD DISLODGED AND COULD NOT BE ADVANCED TO AN ACCEPTABLE LOCATION. THE LEAD 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 THERE WERE UNACCEPTABLE THRESHOLDS AND THAT THE LEAD DISLODGED AND WAS UNABLE TO ADVANCE. IT WAS FURTHER REPORTED THAT THERE WAS INTERMITTENT LOSS OF CAPTURE. THE LEAD 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 SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO, INC. 4092-52 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| SEDR01 IMPLANTABLE PULSE GENERATOR