BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSIA IPG

    MDR report key: 18806927 · Received February 29, 2024

    Report

    Report Number
    3004209178-2024-05977
    Event Type
    Death
    Date Received
    February 29, 2024
    Date of Event
    December 6, 2023
    Report Date
    February 29, 2024
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    UDI-DI
    00613994222138
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 5076-45 LEAD IMPLANTED (B)(6) 2013. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A PATIENT REPRESENTATIVE THAT THE PATIENT DIED. PRIOR TO THE PATIENT'S PASSING, THE PATIENT¿S RELATIVE NOTED THAT THE PATIENT¿S IMPLANTABLE PULSE GENERATOR (IPG) WENT INTO ¿BATTERY SAVING MODE¿ FOR A YEAR AND THE PATIENT "WASN'T ABLE TO STAND OR WALK" AND THEY COULDN¿T GET THE PATIENT DRESSED. THE PATIENT REPRESENTATIVE FURTHER REPORTED THAT THE PATIENT WAS "CHOKING ON THEIR SALIVA" AND COULDN¿T HOLD THEIR HEAD UP AND THE PATIENT WAS SO WEAK, THEY BECAME BED RIDDEN. THE PATIENT¿S IPG WAS EVENTUALLY EXPLANTED AND REPLACED, BUT WAS PUT ON HOSPICE CARE AFTER THIS. SIX DAYS LATER, THE PATIENT PASSED AWAY DUE TO UNKNOWN REASONS.  ADDITIONAL INFORMATION RELATED TO THE CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444776 SENSIA IPG PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO SEDR01 00613994222138

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Male Death 5092-58 LEAD