BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA DR

    MDR report key: 12583389 · Received October 6, 2021

    Report

    Report Number
    2182208-2021-03969
    Event Type
    Death
    Date Received
    October 6, 2021
    Date of Event
    January 1, 2021
    Report Date
    October 6, 2021
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/ LOT NUMBERS. THE BASELINE GENDER/ AGE CHARACTERISTICS IS MALE/ (B)(6) YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. THE DATE OF DEATH IS NOT AVAILABLE AT THE TIME OF THIS REPORT; AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: FEASIBILITY OF SPINAL CORD STIMULATION IN PATIENTS WITH REFRACTORY ANGINA PECTORIS AND A CARDIAC IMPLANTED ELECTRONIC DEVICE. NEUROMODULATION. 2021. DOI: 10.1111/NER.13411. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING INTERFERENCE BETWEEN SPINAL CORD STIMULATION AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD). THE ARTICLE REPORTS NO INTERFERENCE BETWEEN THE SPINAL CORD STIMULATORS AND THE ICD IN THE STUDY TIME FRAME, BUT IN THE FOLLOW UP PERIOD, THERE WERE TWO DEATHS. THE CAUSES OF DEATH ARE UNKNOWN, BUT IT WAS NOTED THAT INTERFERENCE COULD NOT BE DISASSOCIATED. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482844 PROTECTA DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC, INC. D334DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death