BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1810143 · Received August 20, 2010

    Report

    Report Number
    2649622-2010-05498
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    February 17, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 FULL LEAD WAS RETURNED AND ANALYZED. THE LEAD APPEARS TO BE BENT HOWEVER IT WAS THE STYLET THAT WAS INSERTED IN THE LEAD THAT WAS BENT. THE HELIX WAS EXTENDED WHEN THE LEAD WAS RECEIVED IN THE LAB.

    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. CORRECTED INITIAL REPORTER TITLE. CORRECTED PATIENTS INVOLVED, PATIENT OUTCOME AND PAT. CODES. EVALUATION SUMMARY:(B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. THE LEAD APPEARS TO BE BENT; HOWEVER, IT WAS THE STYLET THAT WAS INSERTED IN THE LEAD THAT WAS BENT. THE HELIX WAS EXTENDED WHEN THE LEAD WAS RECEIVED IN THE LAB. STYLET: STYLET BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE LEAD APPEARED BROKEN AT THE PROXIMAL END. THE DAMAGE WAS NOTICED UPON OPENING OF THE PACKAGE AND BEFORE THE IMPLANT ATTEMPT. THE DEVICE WAS NOT USE IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE LEAD APPEARED BROKEN AT THE PROXIMAL END. THE DAMAGE WAS NOTICED UPON OPENING OF THE PACKAGE AND BEFORE THE IMPLANT ATTEMPT. THE DEVICE WAS NOT USE IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE STYLET WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention