BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENRHYTHM DR

    MDR report key: 2468299 · Received February 24, 2012

    Report

    Report Number
    2647346-2012-00165
    Event Type
    Death
    Date Received
    February 24, 2012
    Date of Event
    December 26, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S38
    Removal / Correction Number
    Z-1440-2010
    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. ADDITIONAL INFORMATION OBTAINED REVEALS THAT APPROXIMATELY TWO MONTHS PRIOR TO DEATH, THE PATIENT PRESENTED AT THE "SUB ACUTE SIDE" OF THE RETIREMENT COMMUNITY WHERE THE PATIENT LIVES WITH AN "ALTERED LEVEL OF CONSCIOUSNESS;" THE RECOMMENDATION WAS MADE TO UPGRADE THE PATIENT'S LEVEL OF CARE. A CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    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 INFORMATION OBTAINED REVEALS THAT APPROXIMATELY TWO MONTHS PRIOR TO DEATH, THE PATIENT PRESENTED AT THE "SUB ACUTE SIDE" OF THE RETIREMENT COMMUNITY WHERE THE PATIENT LIVES WITH AN "ALTERED LEVEL[ ] OF CONSCIOUSNESS;" THE RECOMMENDATION WAS MADE TO UPGRADE THE PATIENT'S LEVEL OF CARE. A CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. EVALUATION SUMMARY: (B)(4)-THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. (B)(4)-THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. ALL CONDUCTORS WERE DISTORTED. THE OUTER INSULATION HAD COSMETIC DEPRESSION. THERE WAS APPARENT EXPLANT DAMAGE. A VISUAL ANALYSIS WAS PERFORMED ONLY. (B)(4)-THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. THE OUTER INSULATION HAD COSMETIC DEPRESSION. A VISUAL ANALYSIS WAS PERFORMED ONLY.

    Description of Event or Problem · 1

    A DUAL CHAMBER IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A COMPETITOR WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY SIX MONTHS POST THE DEVICE SYSTEM IMPLANT.

    Description of Event or Problem · 1

    A DUAL CHAMBER IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A COMPETITOR WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY SIX MONTHS POST THE DEVICE SYSTEM IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENRHYTHM DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. P1501DR

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death