BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 4956187 · Received July 31, 2015

    Report

    Report Number
    2649622-2015-07807
    Event Type
    Death
    Date Received
    July 31, 2015
    Date of Event
    December 15, 2014
    Report Date
    July 2, 2015
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED. VISUAL SUMMARY ANALYSIS OF THE LEAD WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE ANALYST COMMENTED THAT TWO 5086 MODEL LEADS WERE RECEIVED FOR ANALYSIS AND THE SERIAL NUMBERS HAD BEEN CUT OFF, THEREFORE, IT CANNOT BE DETERMINED WHICH SERIAL NUMBER EACH LEAD BELONGED TO.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A FUNERAL HOME WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY 7 MONTHS AFTER THE DEVICE SYSTEM WAS IMPLANTED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED, HOWEVER IT WAS REPORTED THAT THE PATIENT WAS IN HOSPICE CARE AND NEVER FOLLOWED UP WITH THEIR PHYSICIAN POST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499734 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI45

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Death