BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMO II DR

    MDR report key: 1660651 · Received April 16, 2010

    Report

    Report Number
    2647346-2010-00141
    Event Type
    Death
    Date Received
    April 16, 2010
    Date of Event
    April 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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.

    Additional Manufacturer Narrative · 1

    (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A "RED ALERT" FOR A LEAD INTEGRITY ISSUE TRANSMITTED (OVERSENSING AND NOISE) AT 7:09AM ON (B) (6) 2010. THE NURSE CALLED THE PATIENT'S HOME WITHIN 30 MINUTES AND WAS TOLD THE PATIENT HAD DIED. THE 3 NON SUSTAINED TACHYCARDIAS HAD OCCURRED BETWEEN 7:07 AND 7:08 AND ALL HAD SHORT INTERVALS (NOISE - SIC 49). LEAD IMPEDANCE WAS NOTED TO BE OKAY. PATIENT HAD A FOLLOW UP APPOINTMENT SCHEDULED WITH THE PHYSICIAN THE FOLLOWING DAY. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A "RED ALERT" FOR A LEAD INTEGRITY ISSUE TRANSMITTED (OVERSENSING AND NOISE) AT 7:09AM ON (B) (6) 2010. THE NURSE CALLED THE PATIENT'S HOME WITHIN 30 MINUTES AND WAS TOLD THE PATIENT HAD DIED. THE 3 NON SUSTAINED TACHYCARDIAS HAD OCCURRED BETWEEN 7:07 AND 7:08 AND ALL HAD SHORT INTERVALS (NOISE - SIC 49). LEAD IMPEDANCE WAS NOTED TO BE OKAY. PATIENT HAD A FOLLOW UP APPOINTMENT SCHEDULED WITH THE PHYSICIAN THE FOLLOWING DAY. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. FOLLOW UP REVEALED THE PATIENT'S WIFE REPORTED THE PATIENT HAD DIED FROM CONGESTIVE HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D284DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| O