BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2790742 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14765
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    PRODUCT EVALUATION SUMMARY: THE FULL LENGTH OF THE LEAD IN SEGMENTS WAS RETURNED, ANALYZED AND THE HELIX WAS FRACTURED FROM BEING PULLED/STRETCHED/OVERSTRESSED. IT WAS NOTED THAT THE DISTAL CONDUCTOR HAD BLOOD (NOT OBSTRUCTED) AND THE EXPOSED SUPERIOR VENA CAVA (SVC) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION CONDUCTOR COILS WERE BOTH KINKED/BUCKLED. THE DISTAL END LOW VOLTAGE ELECTRODE WAS COVERED WITH BLOOD AND BODY TISSUE/FIBROTIC GROWTH AND WAS DAMAGED FROM BEING PULLED/STRETCHED/OVERSTRESSED. THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND THE OUTER TUBING OVER LAY WAS BREACHED FROM BEING MELTED. THE LEAD HAD APPARENT EXPLANT DAMAGE. THE ANALYST COMMENTED THAT PER SCANNING ELECTRON MICROSCOPY, THE HELIX WIRE FRACTURED BY AN OVERLOAD CONDITION WITH A TORSIONAL COMPONENT WHICH IS INDICATED BY THE STEP IN THE FRACTURE FACE. THE HELIX, AT THE SHANK, IS SUPPOSED TO HAVE APPROXIMATELY 2.5 WIRE TURNS AND THIS LEAD HAS NONE, SO THE WELD WAS PROBABLY ALSO CLOSE TO FRACTURING. THE HELIX WIRE IS ALSO STRETCHED OUT INDICATING A LARGE TENSILE LOAD WAS APPLIED (WHICH TRANSLATES INTO A TORSION FOR A COIL). IT WAS TRIED TO ESTIMATE HOW MUCH OF THE HELIX IS MISSING AND APPROXIMATELY 1 AND 1/2 TURNS OF THE WIRE ARE MISSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS T-WAVE OVERSENSING AND AN INCREASE IN RIGHT VENTRICULAR PACING IMPEDANCE FROM 700 OHMS TO 2000 OHMS. IT WAS ALSO REPORTED THAT THE UNSTABLE IMPEDANCES OCCURRED OVER SEVERAL WEEKS. IT WAS FURTHER REPORTED THAT THERE WAS AN INCREASE IN THRESHOLDS. THE SENSITIVITY WAS CHANGED. THE PATIENT WILL BE SCHEDULED FOR FURTHER EVALUATION. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS T-WAVE OVERSENSING AND AN INCREASE IN RIGHT VENTRICULAR PACING IMPEDANCE FROM 700 OHMS TO 2000 OHMS. IT WAS ALSO REPORTED THAT THE UNSTABLE IMPEDANCES OCCURRED OVER SEVERAL WEEKS. IT WAS ALSO REPORTED THAT THERE WAS AN INCREASE IN THRESHOLDS. THE SENSITIVITY WAS CHANGED. IT WAS FURTHER REPORTED THAT DURING THE EXTRACTION OF THE LEAD AN ATTEMPT TO RETRACT THE HELICAL SCREW WAS NOT SUCCESSFUL. THEREFORE THE VERY TIP OF THE HELICAL SCREW WAS LEFT IN THE MYOCARDIUM. IT WAS NOTED THAT THIS LIKELY REPRESENTS THE EXPLANATION FOR THE HIGH IMPEDANCE AND CAPTURE THRESHOLDS ASSOCIATED WITH THE LEAD. NO FURTHER 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 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R D284DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| D284DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD