BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO

    MDR report key: 2994315 · Received March 8, 2013

    Report

    Report Number
    2649622-2013-02512
    Event Type
    Death
    Date Received
    March 8, 2013
    Date of Event
    November 10, 2012
    Report Date
    March 11, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. (B)(4). CONCOMITANT PRODUCT: 4193 IMPLANTABLE PACING LEAD, (B)(6) 2003.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN'S OFFICE NOTED THAT THE PATIENT HAD A RESPIRATORY AND CARDIAC ARREST IN THE OFFICE. AFTER RESUSCITATION THE PATIENT HAD SEVERE NEUROLOGICAL IMPAIRMENT, NO NEUROLOGICAL RESPONSE AND VENTRICULAR TACHYCARDIA. THE PATIENT WAS MADE A DO NOT RESUSCITATE AND DIED. THE CAUSE OF DEATH WAS REPORTED AS RESPIRATORY AND CARDIAC ARREST, RENAL INSUFFICIENCY, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HYPERTENSION AND ATRIAL FIBRILLATION. THE PATIENT WAS NOTED TO HAVE AN EJECTION FRACTION OF 15 PERCENT. THERE WERE NO DEVICE ALLEGATIONS RELATED TO THE PATIENT DEATH. PRODUCT EVENT SUMMARY: (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THERE WAS APPARENT EXPLANT DAMAGE.

    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.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A FUNERAL HOME WITH INFORMATION INDICATING THE PATIENT IS DECEASED. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY FOUR MONTHS AFTER DEVICE REPLACEMENT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A FUNERAL HOME WITH INFORMATION INDICATING THE PATIENT IS DECEASED. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY FOUR MONTHS AFTER DEVICE REPLACEMENT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100312 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Death (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR