BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1072507 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03712
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    April 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 AND ANALYZED.

    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) NO ANOMALIES WERE FOUND. FULL LEAD RETURNED AND ANALYZED.(B) (4) ANALYSIS HAS BEEN SUSPENDED DUE TO PRODUCT MISFILING. IF LOCATED, ANALYSIS WILL BE COMPLETED AND THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 6947 LEAD WAS REPLACED DUE TO OVERSENSING AND NOISE ON THE LEAD. OVERSENSING WAS EXPERIENCED WITH THE REPLACEMENT LEAD. IT WAS SUSPECTED THAT THE PROBLEM WAS CAUSED BY FLUID THAT MAY HAVE ENTERED THE DEVICE HEADER. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. A SECOND DEVICE WAS ATTEMPTED WITH THE SAME RESULT (OVERSENSING) AND IT WAS ALSO SUSPECTED THAT FLUID MAY HAVE ENTERED THIS DEVICE AS WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 6947 LEAD WAS REPLACED DUE TO OVERSENSING AND NOISE ON THE LEAD. OVERSENSING WAS EXPERIENCED WITH THE REPLACEMENT LEAD. IT WAS SUSPECTED THAT THE PROBLEM WAS CAUSED BY FLUID THAT MAY HAVE ENTERED THE DEVICE HEADER. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. A SECOND DEVICE WAS ATTEMPTED WITH THE SAME RESULT (OVERSENSING) AND IT WAS ALSO SUSPECTED THAT FLUID MAY HAVE ENTERED THIS DEVICE AS WELL. IT WAS REPORTED THAT DURING ATTEMPTED IMPLANT OF DEVICE (B) (4) OVERSENSING WAS OBSERVED. THE DEVICE WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS WERE 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 LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention