BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2053293 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05842
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 1, 2011
    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
    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. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL.

    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 FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR FRACTURED. IT WAS NOTED THAT THE DEFIBRILLATION CONDUCTOR FRACTURED, THE DEFIBRILLATION COIL WAS DISTORTED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIBRILLATION COIL, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THE HELIX WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THE GUIDETOOTH WAS DAMAGED. THE ANALYST COMMENTED THAT THE LEAD APPEARS TO HAVE BEEN IMPLANTED WITH A BEND IN IT AT THE FRACTURE SITE. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WAS OVERSENSING WITH VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA) LESS THAN EQUAL TO 210 MS BETWEEN (B)(4) 2012 AND (B)(4) 2012. INTERFERENCE/NOISE WITH V-SIC (VENTRICULAR SHORT INTERVAL COUNT) EQUALING 544.4 COUNTS AVG/DAY, IN 1.62 DAYS, BETWEEN (B)(4) 2012 AND (B)(4) 2012. HIGH RESISTANCE/IMPEDANCE WITH PATIENT ALERTS FOR OUT OF TOLERANCE SUB THRESHOLD LEAD IMPEDANCE ON (B)(4) 2012 AND (B)(4) 2012. WEEKLY HIGH VOLTAGE LEAD IMPEDANCE TREND DATA SHOWS AN ABRUPT INCREASE FOR MIN AND MAX SVC (SUPERIOR VENA CAVA) DEFIB IMPEDANCE EQUALING 65 TO 254 OHMS PEAK BETWEEN (B)(4) 2011 AND (B)(4) 2012. ALSO, A LEAD INTEGRITY ALERT TRIGGERED WITH PATIENT ALERT FOR LEAD FAILURE PREDICTOR ON (B)(4) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD SUPERIOR VENA CAVA (SVC) COIL HAD OUT OF RANGE IMPEDANCE. THE LEAD REMAINS IN USE. IT WAS LATER REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO HEARING THE LEAD INTEGRITY ALERT WHICH WAS TRIGGERED DUE TO OVERSENSING AND THE RV LEAD SVC COIL HAVING HIGH IMPEDANCE. ALSO THERE WAS AN APPARENT FRACTURE OF THE RV LEAD SVC COIL WHICH HAD BEEN PREVIOUSLY INACTIVATED. THE RV LEAD WAS 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 THE RIGHT VENTRICULAR LEAD COIL HAD OUT OF RANGE IMPEDANCE. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O| R 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| D224DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| D224DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB