BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMO DR

    MDR report key: 1994137 · Received February 16, 2011

    Report

    Report Number
    6000094-2011-00343
    Event Type
    Death
    Date Received
    February 16, 2011
    Date of Event
    November 21, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT DIED AT HOME SUDDENLY. THE INDICATION FOR THE DEFIBRILLATOR WAS VENTRICULAR FIBRILLATION ON CORONARY SPASM AND AFTER A RECOVERED SUDDEN CARDIAC ARREST. CAUSE OF DEATH IS UNKNOWN AT THIS TIME. CORRECTION MADE TO EVALUATION SUMMARY: (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE ALL CONDUCTORS WERE STRETCHED, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): THE LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION. (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND FOUND TO HAVE NORMAL BATTERY DEPLETION. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER FOR THE 6935, THE MANUFACTURING DATE CANNOT BE DETERMINED. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE ALL CONDUCTORS WERE STRETCHED, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE. 5076: THE LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION. (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND FOUND TO HAVE NORMAL BATTERY DEPLETION. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER FOR THE 6935 AND 5076, THE MANUFACTURING DATE CANNOT BE DETERMINED. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF A LEAD AND DEVICE ARE IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER FOR THE 6935 AND 5076, THE MANUFACTURING DATE CANNOT BE DETERMINED. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WITH AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) DIED. THE ICD WAS REMOVED AND INTERROGATED POST MORTEM. THERE WAS AN "EPISODE" FOUND ON THE DAY OF DEATH WITHOUT AN ELECTROGRAM. CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7278 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death