BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2130408 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10161
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVY
    PMA / PMN Number
    P920015/S055
    Removal / Correction Number
    Z-0475-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. PRIMARY RESULTS REVEALED NO ANOMALIES FOUND. THE INNER INSULATION WAS KINKED/BUCKLED. BLOOD WAS PRESENT IN/ON THE HELIX/LOBE MECHANISM AND SLEEVE HEAD. THE WAS ALSO APPARENT DAMAGE AT IMPLANT.

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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. PRIMARY RESULTS REVEALED NO ANOMALIES FOUND. THE INNER INSULATION WAS KINKED/BUCKLED. BLOOD WAS PRESENT IN/ON THE HELIX/LOBE MECHANISM AND SLEEVE HEAD. THE WAS ALSO APPARENT DAMAGE AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEAD WAS REPOSITIONED IN ORDER TO FIND A BETTER SENSING LOCATION. WHEN TRYING TO RE-EXTEND THE HELIX, THE HELIX WOULD NOT EXTEND. THE LEAD WAS NOT USED, AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THE HELIX WAS ROTATED 20 TO 25 TIMES DURING THE INITIAL POSITIONING ATTEMPT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEAD WAS REPOSITIONED IN ORDER TO FIND A BETTER SENSING LOCATION. WHEN TRYING TO RE-EXTEND THE HELIX, THE HELIX WOULD NOT EXTEND. THE LEAD WAS NOT USED, AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD NVY MEDTRONIC PUERTO RICO, INC. 6947M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other