BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3133629 · Received May 29, 2013

    Report

    Report Number
    2649622-2013-05436
    Event Type
    Death
    Date Received
    May 29, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THE CAUSE OF DEATH IS UNKNOWN AND NO FURTHER INFORMATION HAS BEEN OBTAINED THUS FAR THAT WOULD/COULD DISASSOCIATE THE DEVICE SYSTEM AND EVENT. THEREFORE THIS EVENT WILL BE PROCESSED WITH THE INFORMATION AT HAND AND WILL BE CAPTURED AS A MEDICAL/DEATH ON INCOMING INFORMATION. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. PRODUCT ID A3DR01 IMPLANTED: 2013 (B)(6); PRODUCT ID 5086MRI52 IMPLANTED: 2013 (B)(6). (B)(4). THE LEAD WAS NOT RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANT PROCEDURE AND LESS THAN A MONTH FROM THE PROCEDURE WAS SEEN IN THE EMERGENCY ROOM DUE TO EXACERBATION OF HEART FAILURE AND WAS DIAGNOSED WITH CARDIAC TAMPONADE AND PERICARDIAL EFFUSION. DURING FOLLOW UP WEEKS LATER, IT WAS REPORTED THAT THE PATIENT WAS DECEASED. THE PHYSICIAN STATED THAT THERE WAS NO CAUSAL ASSOCIATION BETWEEN THE DEATH AND THE DEVICE, HOWEVER THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235938 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Death