BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1797856 · Received August 12, 2010

    Report

    Report Number
    2649622-2010-08567
    Event Type
    No answer provided
    Date Received
    August 12, 2010
    Report Date
    January 6, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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) NO ANOMALIES WERE FOUND. THE FULL LEAD WAS RETURNED AND ANALYZED. BLOOD/BODY FLUID WAS PRESENT ON THE DISTAL CONDUCTOR. (B)(4) NO ANOMALIES WERE FOUND. THE FULL LEAD WAS RETURNED AND ANALYZED. BLOOD WAS PRESENT ON THE OUTER TUBING OVERLAY AND IN/ON THE HELIX MECHANISM. THE OUTER TUBING OVERLAY WAS MELTED.

    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) NO ANOMALIES WERE FOUND. THE FULL LEAD WAS RETURNED AND ANALYZED. BLOOD/BODY FLUID WAS PRESENT ON THE DISTAL CONDUCTOR. (B)(4) OUTER TUBING OVERLAY MELTED. THE FULL LEAD WAS RETURNED AND ANALYZED. BLOOD WAS PRESENT ON THE OUTER TUBING OVERLAY AND IN/ON THE HELIX MECHANISM. APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE AND LEAD ARE IN PROCESS; RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR LV LEAD REPLACEMENT DUE TO DIAPHRAMATIC STIMULATION. THE 4193 LV LEAD WAS CAPPED. DURING THE IMPLANT ATTEMPT, THE 4194 LV LEAD WAS NOT USED BECAUSE OF INABILITY TO PLACE IN THE TARGET BRANCH. THE 4193 LV LEAD WAS REPLACED WITH A 4196 LV LEAD. IN ADDITION, THE 6947 RV LEAD WAS NOTED TO BE KINKED WITH INSULATION BREAK NEAR THE DISTAL PINS. PHYSICIAN MADE DECISION TO REPLACE 6947 RV LEAD WITH 6935 RV LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LV LEAD WAS CAPPED AND REPLACED DUE TO DIAPHRAGMATIC STIMULATION. ANOTHER LV LEAD WAS ATTEMPTED, BUT NOT IMPLANTED BECAUSE IT COULD NOT BE PLACED IN THE TARGET BRANCH. ANOTHER LV LEAD WAS SUCCESSFULLY IMPLANTED. IT WAS ALSO REPORTED THAT THE 6947 RV LEAD WAS NOTED TO BE KINKED WITH INSULATION BREAK NEAR THE DISTAL PINS. THE LEAD WAS EXPLANTED AND REPLACED. 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 CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB