BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 6015487 · Received October 10, 2016

    Report

    Report Number
    2649622-2016-13764
    Event Type
    Death
    Date Received
    October 10, 2016
    Date of Event
    July 22, 2016
    Report Date
    October 6, 2016
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: .SEX .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS DECEASED. THE PATIENT PRESENTED WITH CONFUSION AND AGITATION. THE PATIENT WAS DIAGNOSED WITH LOW OUTPUT HEART FAILURE WITH ASSOCIATED MULTI-ORGAN FAILURE AND ENDOCARDITIS (BLOOD CULTURES WERE POSITIVE FOR STAPH EPIDERMIDIS). THE SOURCE OF THE ENDOCARDITIS WAS NOT REPORTED. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS AND PRESSORS. THE PATIENT HAD MULTIPLE RUNS OF NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) AND SO WAS ALSO COMMENCED ON AMIODARONE. DESPITE A WEEK OF MEDICAL TREATMENT, THE PATIENT REMAINED STABLE BUT DID NOT IMPROVE. THE SEVERE HEART FAILURE AND ENDOCARDITIS PERSISTED. THE PATIENT WAS PLACED ON SUPPORTIVE TREATMENT AND COMFORT CARE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS TURNED OFF. THE PATIENT WAS TRANSFERRED TO HOSPICE CARE. THERE WAS NO ALLEGED PRODUCT ISSUE WITH THE ICD AND/OR LEADS. THE PATIENT WAS A PARTICIPANT IN THE ADAPT RESPONSE STUDY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665809 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death (B)(4) FICD, 5076-52 LEAD, 459888 LEAD