BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 1792289 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-07062
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    May 3, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. CORRECTIONS: UPDATED INITIAL REPORTER CONTACT ADDRESS. EVALUATION SUMMARY: (B)(4) THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE DEVICE SHOWED THE RV PACE IMPEDANCE MEASUREMENT WAS IN THE 800 - 900 OHM RANGE (WAS ONE VALUE OF 1040 OHMS IN (B)(6) 2009) UNTIL THE WEEK ENDING (B)(6) 2010 WHEN THE MAX VALUE WAS 1008 OHMS. THIS VALUE CONTINUED TO INCREASE THROUGH THE END OF THE RECORD WITH THE WEEK ENDING (B)(6) 2010 WHEN THE MIN/MAX VALUE WAS 1824/2208 OHMS. THE LEAD HAS BEEN SUBSEQUENTLY RETURNED AND 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. EVALUATION SUMMARY: (B)(4) THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE DEVICE SHOWED THE RV PACE IMPEDANCE MEASUREMENT WAS IN THE 800 - 900 OHM RANGE (WAS ONE VALUE OF 1040 OHMS IN (B)(6) 2009) UNTIL THE WEEK ENDING (B)(6) 2010 WHEN THE MAX VALUE WAS 1008 OHMS. THIS VALUE CONTINUED TO INCREASE THROUGH THE END OF THE RECORD WITH THE WEEK ENDING (B)(6) 2010 WHEN THE MIN/MAX VALUE WAS 1824/2208 OHMS. EVALUATION SUMMARY (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATATDC070004V COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. (B)(4) IMPEDANCE - RESISTANCE/IMPEDANCE INCREASE (B)(4) THE RV PACE IMPEDANCE MEASUREMENT WAS IN THE 800 - 900 OHM RANGE (WAS ONE VALUE OF 1040 OHMS IN (B)(6) 2009) UNTIL THE WEEK ENDING (B)(6) 2010 WHEN THE MAX VALUE WAS 1008 OHMS. THIS VALUE CONTINUED TO INCREASE THROUGH THE END OF THE RECORD WITH THE WEEK ENDING (B)(6) 2010 WHEN THE MIN/MAX VALUE WAS 1824/2208 OHMS.

    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) THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE DEVICE SHOWED THE RV PACE IMPEDANCE MEASUREMENT WAS IN THE 800 - 900 OHM RANGE (WAS ONE VALUE OF 1040 OHMS IN (B)(6) 2009) UNTIL THE WEEK ENDING (B)(6) 2010 WHEN THE MAX VALUE WAS 1008 OHMS. THIS VALUE CONTINUED TO INCREASE THROUGH THE END OF THE RECORD WITH THE WEEK ENDING (B)(6) 2010 WHEN THE MIN/MAX VALUE WAS 1824/2208 OHMS. (B)(4) THE LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DEFIBRILLATION CONDUCTOR WAS DISTORTED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIB COIL, THERE WAS A WHITE SUBSTANCE ON THE OUTER TUBING OVERLAY, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD IMPEDANCE INCREASED FROM 800 OHMS TO >3500 OHMS. ALSO IT WAS REPORTED THAT THERE WAS ONE EPISODE OF OVERSENSING BUT NO REPORTS OF INAPPROPRIATE SHOCKS. A NON-REPARABLE INSULATION BREACH WAS NOTED UPON REPLACEMENT OF THE LEAD. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD IMPEDANCE INCREASED FROM 800 OHMS TO >3500 OHMS. THE LEAD IS STILL 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| O| R 5592 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5592 IMPLANTABLE PACING LEAD