BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1864688 · Received October 12, 2010

    Report

    Report Number
    2649622-2010-10668
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    July 30, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4): WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. VENTRICULAR SHORT INTERVAL COUNT V-SIC=8.6 COUNTS AVG/DAY, IN 42.11 DAYS, BETWEEN (B)(4) 2010 14:31:19 AND (B)(6) 2010 17:13:45. (B)(4) NO ANOMALIES FOUND. FULL LEAD RETURNED AND ANALYZED. ADDITIONAL OBSERVATIONS OF INNER TUBING KINKED/BUCKLED, OUTER TUBING OVERLAY COSMETIC ENVIRONMENTAL STRESS CRACKING AND APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE FIRST FOLLOW-UP VISIT POST-IMPLANT, THE R-WAVE AMPLITUDE HAD DECREASED AND RV LEAD SLACK HAD DECREASED FROM IMPLANT OBSERVATIONS. ALL OTHER ELECTRICAL MEASUREMENTS WERE ACCEPTABLE. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE FIRST FOLLOW-UP VISIT POST-IMPLANT, THE R-WAVE AMPLITUDE HAD DECREASED AND THE RIGHT VENTRICULAR (RV) LEAD SLACK HAD DECREASED FROM IMPLANT OBSERVATIONS. ALL OTHER ELECTRICAL MEASUREMENTS WERE ACCEPTABLE. IT WAS LATER REPORTED THAT THERE WAS AN INCREASE IN THE SENSING INTEGRITY COUNTER (SIC) NUMBER FROM THE RV LEAD OVERSENSING AND ALSO AN INCREASE IN THRESHOLDS. IT WAS FURTHER REPORTED THAT THE LEAD HAD BEEN 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 ON THE FIRST FOLLOW-UP VISIT POST-IMPLANT, THE R-WAVE AMPLITUDE HAD DECREASED AND RV LEAD SLACK HAD DECREASED FROM IMPLANT OBSERVATIONS. ALL OTHER ELECTRICAL MEASUREMENTS WERE ACCEPTABLE. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE LEAD HAS BEEN 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 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5594 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5594 IMPLANTABLE PACING LEAD| 5594 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB