BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 1874802 · Received October 19, 2010

    Report

    Report Number
    2649622-2010-11563
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    March 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD IS COMING OUT OF THE PACKAGE WITH A CANT AT THE DISTAL END. THE PHYSICIAN SAID THAT HE WILL STOP USING THESE LEADS UNTIL WE FIX THIS ISSUE. THE LEAD IS STILL IN USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD IS COMING OUT OF THE PACKAGE WITH A CANT AT THE DISTAL END. THE PHYSICIAN SAID THAT HE WILL STOP USING THESE LEADS UNTIL WE FIX THIS ISSUE. THE LEAD IS STILL IN USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED AND THE FOLLOWING WAS NOTED: THE LEAD PRESENTS WELL IN THE INNER PACKAGING. HOWEVER, WHEN THE LEAD IS REMOVED FROM ITS INNER PACKAGING, A SLIGHT CANT AT THE DISTAL END TOWARDS THE TIP OCCURS. CONSEQUENTLY, THE PHYSICIAN HAS A CONCERN THE SLIGHT CANT MAY IMPACT HOW THE LEAD WILL INTERFACE WITH THE TISSUE. THE LEAD REMAINS IN USE. 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other 4542 COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD