BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1922037 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12733
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND INDICATED HIGH RESISTANCE/IMPEDANCE, NOISE AND OVERSENSING. THE MAXIMUM RIGHT VENTRICULAR PACING IMPEDANCE ABRUPTLY SPIKED FOR THE WEEK ENDING (B)(6) 2010, BEFORE RETURNING TO NOMINAL IMPEDANCES THE FOLLOWING WEEK. A HIGH NUMBER OF SHORT INTEGRITY COUNTERS AND 15 SHORT V-V CYCLE EPISODES WERE NOTED IN THE DATA.

    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) A PORTION OF THE LEAD WAS RETURNED IN SEGMENTS WHERE IT WAS DISCOVERED THAT THE DISTAL CONDUCTOR WAS FRACTURED. THE DEFIBRILLATION CONDUCTOR WAS DISTORTED; THERE WAS BLOOD/BODY FLUID OBSERVED ON SEVERAL CONDUCTORS, IN/ON THE HELIX MECHANISM AND SLEEVEHEAD. THE OUTER INSULATION HAD COSMETIC DEPRESSION AND ENVIRONMENTAL STRESS CRACKING. THE OUTER TUBING WAS TORN. THERE WAS INTERMITTENCY BETWEEN THE CONNECTOR PIN AND CAP. THE LEAD WAS STRETCHED, AND A TIP SEAL OBSERVATION. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND INDICATED HIGH RESISTANCE/IMPEDANCE, NOISE AND OVERSENSING. THE MAXIMUM RIGHT VENTRICULAR PACING IMPEDANCE ABRUPTLY SPIKED FOR THE WEEK ENDING (B)(6) 2010, BEFORE RETURNING TO NOMINAL IMPEDANCES THE FOLLOWING WEEK. A HIGH NUMBER OF SHORT INTEGRITY COUNTERS AND 15 SHORT V-V CYCLE EPISODES WERE NOTED IN THE DATA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS OVERSENSING AND MALFUNCTIONED. THE PATIENT RECEIVED INAPPROPRIATE SHOCKS. THE LEAD CAME APART DURING EXTRACTION. IT WAS LATER REPORTED THAT THE LEAD FRACTURED. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER 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 79 YR Hospitalization| L| R 1688T COMPETITOR IMPLANTABLE PACING LEAD| 1688T COMPETITOR IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD