BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 1925168 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13735
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0474-2011
    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. EVALUATION SUMMARY: (B)(4) : THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. (B)(4) : THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED) AND THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING.

    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 SPRINT QUATTRO LEAD IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED) AND THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT VENTRICULAR (RV) LEAD WAS DETERIORATING VERY RAPIDLY. THE PATIENT HAD SLOWLY INCREASING RV COIL IMPEDANCES. THERE WAS EVIDENCE OF T-WAVE OVERSENSING. DEFIBRILLATION THRESHOLDS WERE INCREASING. UNDERSENSING WAS ALSO REPORTED. THE RV LEAD WAS EXTRACTED AND REPLACED. IT WAS ALSO REPORTED THE LEFT VENTRICULAR LEAD WAS IN A SUB-OPTIMAL POSITION AND WAS EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT VENTRICULAR (RV) LEAD WAS DETERIORATING VERY RAPIDLY. THE PATIENT HAD SLOWLY INCREASING RV COIL IMPEDANCES. THERE WAS EVIDENCE OF T-WAVE OVERSENSING. DEFIBRILLATION THRESHOLDS WERE INCREASING. UNDERSENSING WAS ALSO REPORTED. THE RV LEAD WAS EXTRACTED AND REPLACED. IT WAS ALSO REPORTED THE LEFT VENTRICULAR LEAD WAS IN A SUB-OPTIMAL POSITION AND WAS EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS FRACTURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT VENTRICULAR (RV) LEAD WAS DETERIORATING VERY RAPIDLY. THE PATIENT HAD SLOWLY INCREASING RV COIL IMPEDANCES. THERE WAS EVIDENCE OF T-WAVE OVERSENSING. DEFIBRILLATION THRESHOLDS WERE INCREASING. UNDERSENSING WAS ALSO REPORTED. THE RV LEAD WAS EXTRACTED AND REPLACED. IT WAS ALSO REPORTED THE LEFT VENTRICULAR LEAD WAS IN A SUB-OPTIMAL POSITION AND WAS EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS FRACTURED. IT WAS LATER REPORTED THAT, WHEN INFORMED OF THE REIMBURSEMENT PROCESS, THE PATIENT STATED THAT THE RIGHT VENTRICULAR LEAD WAS "FAULTY" AND THE PATIENT WAS DISSATISFIED WITH THE SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT VENTRICULAR (RV) LEAD WAS DETERIORATING VERY RAPIDLY. THE PATIENT HAD SLOWLY INCREASING RV COIL IMPEDANCES. THERE WAS EVIDENCE OF T-WAVE OVERSENSING. DEFIBRILLATION THRESHOLDS WERE INCREASING. UNDERSENSING WAS ALSO REPORTED. THE RV LEAD WAS EXTRACTED AND REPLACED. IT WAS ALSO REPORTED THE LEFT VENTRICULAR LEAD WAS IN A SUB-OPTIMAL POSITION AND WAS EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS FRACTURED. IT WAS LATER REPORTED THAT, WHEN INFORMED OF THE REIMBURSEMENT PROCESS, THE PATIENT STATED THAT THE RIGHT VENTRICULAR LEAD WAS "FAULTY" AND THE PATIENT WAS DISSATISFIED WITH THE SERVICE. IT WAS LATER REPORTED THAT THE LEAD WAS OVERSENSING AND HAD SUSTAINED FAILURE TO CAPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB