BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2884039 · Received December 21, 2012

    Report

    Report Number
    6000030-2012-00231
    Event Type
    Death
    Date Received
    December 21, 2012
    Date of Event
    March 23, 2012
    Report Date
    December 21, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P950024/S002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT'S PHYSICIAN'S OFFICE INDICATING THE PATIENT'S CAUSE OF DEATH WAS "NOT PACEMAKER RELATED." THE PATIENT HAD SURGERY FOR A NON-DEVICE SYSTEM RELATED REASON, AND DIED FROM COMPLICATIONS OF THAT SURGICAL PROCEDURE. EVENT SUMMARY: (B)(4) - THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. THE PROXIMAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED).

    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4). ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. THIS EVENT WILL BE PROCESSED WITH THE INFORMATION AT HAND. SHOULD ADDITIONAL INFORMATION BECOME KNOWN, IT WILL BE ADDED TO THE EVENT AND PROCESSED ACCORDINGLY.

    Description of Event or Problem · 1

    A DUAL CHAMBER IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY SEVEN DAYS POST THE DEVICE SYSTEM IMPLANT. A CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4968-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR Death 4968-35 IMPLANTABLE PACING LEAD