BEUDAMED
    FDA Adverse Event Death Summary report: N

    REPLY

    MDR report key: 9659181 · Received February 3, 2020

    Report

    Report Number
    1000165971-2020-00246
    Event Type
    Death
    Date Received
    February 3, 2020
    Date of Event
    January 5, 2020
    Report Date
    March 31, 2020
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H1 (TYPE OF REPORTABLE EVENT) CORRECTED.

    Additional Manufacturer Narrative · 0

    PRELIMINARY ANALYSIS REVEALED THAT THE DEVICE HAS BEEN STERILIZED AND RELEASED ACCORDING TO ALL APPLICABLE PROCEDURES. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED BASED ON AVAILABLE DATA.

    Description of Event or Problem · 0

    REPORTEDLY, THE PATIENT WENT TO THE EMERGENCY ON (B)(6) 2020 BECAUSE OF A CONVULSIVE SEIZURE. IT WAS NOT POSSIBLE TO INTERROGATE THE PACEMAKER WITH FOUR DIFFERENT PROGRAMMERS, THOUGH THE INDUCTIVE TELEMETRY HEAD WAS PLACED OVER THE DEVICE; NO GREEN LIGHT APPEARED. AS A RECENTLY EXPLANTED PACEMAKER COULD BE SUCCESSFULLY INTERROGATED, ELECTROMAGNETIC INTERFERENCES (EMI) WERE EXCLUDED. THE ECG SHOWED AN INTRINSIC RHYTHM AROUND 60-65 BPM THOUGH THE DEVICE WAS PROGRAMMED IN VVI MODE WITH A BASIC RATE AT 70 MIN-1. NO PACING SPIKES WERE NOTICED. WHEN A MAGNET WAS APPLIED, ABSENCE OF PACEMAKER REACTION WAS OBSERVED. THE PATIENT IS CURRENTLY HOSPITALIZED IN THE INTENSIVE CARE UNIT. DURING THE PREVIOUS FOLLOW-UP PERFORMED ON 15 NOVEMBER 2019, THE ESTIMATED RESIDUAL LONGEVITY DISPLAYED WAS 3 YEARS AND THE PACING OUTPUTS WERE REPROGRAMMED AT 5.0 V/0.75 MS, BECAUSE THE THRESHOLD INCREASED. THE SITE REPORTED ON (B)(6) 2020 THAT THE PATIENT DIED (EXACT DATE UNKNOWN) FROM AN INFECTION AND WAS CREMATED ON (B)(6) 2020.

    Description of Event or Problem · 0

    REPORTEDLY, THE PATIENT WENT TO THE EMERGENCY ON (B)(6)2020 BECAUSE OF A CONVULSIVE SEIZURE. IT WAS NOT POSSIBLE TO INTERROGATE THE PACEMAKER WITH FOUR DIFFERENT PROGRAMMERS, THOUGH THE INDUCTIVE TELEMETRY HEAD WAS PLACED OVER THE DEVICE; NO GREEN LIGHT APPEARED. AS A RECENTLY EXPLANTED PACEMAKER COULD BE SUCCESSFULLY INTERROGATED, ELECTROMAGNETIC INTERFERENCES (EMI) WERE EXCLUDED. THE ECG SHOWED AN INTRINSIC RHYTHM AROUND 60-65 BPM THOUGH THE DEVICE WAS PROGRAMMED IN VVI MODE WITH A BASIC RATE AT 70 MIN-1. NO PACING SPIKES WERE NOTICED. WHEN A MAGNET WAS APPLIED, ABSENCE OF PACEMAKER REACTION WAS OBSERVED. THE PATIENT IS CURRENTLY HOSPITALIZED IN THE INTENSIVE CARE UNIT. DURING THE PREVIOUS FOLLOW-UP PERFORMED ON (B)(6)2019 , THE ESTIMATED RESIDUAL LONGEVITY DISPLAYED WAS 3 YEARS AND THE PACING OUTPUTS WERE REPROGRAMMED AT 5.0 V/0.75 MS, BECAUSE THE THRESHOLD INCREASED. THE SITE REPORTED ON (B)(6)2020 THAT THE PATIENT DIED (EXACT DATE UNKNOWN) FROM AN INFECTION AND WAS CREMATED ON (B)(6)2020.

    Description of Event or Problem · 0

    REPORTEDLY, THE PATIENT WENT TO THE EMERGENCY ON (B)(6) 2020 BECAUSE OF A CONVULSIVE SEIZURE. IT WAS NOT POSSIBLE TO INTERROGATE THE PACEMAKER WITH FOUR DIFFERENT PROGRAMMERS, THOUGH THE INDUCTIVE TELEMETRY HEAD WAS PLACED OVER THE DEVICE; NO GREEN LIGHT APPEARED. AS A RECENTLY EXPLANTED PACEMAKER COULD BE SUCCESSFULLY INTERROGATED, ELECTROMAGNETIC INTERFERENCES (EMI) WERE EXCLUDED. THE ECG SHOWED AN INTRINSIC RHYTHM AROUND 60-65 BPM THOUGH THE DEVICE WAS PROGRAMMED IN VVI MODE WITH A BASIC RATE AT 70 MIN-1. NO PACING SPIKES WERE NOTICED. WHEN A MAGNET WAS APPLIED, ABSENCE OF PACEMAKER REACTION WAS OBSERVED. THE PATIENT IS CURRENTLY HOSPITALIZED IN THE INTENSIVE CARE UNIT. DURING THE PREVIOUS FOLLOW-UP PERFORMED ON 15 NOVEMBER 2019, THE ESTIMATED RESIDUAL LONGEVITY DISPLAYED WAS 3 YEARS AND THE PACING OUTPUTS WERE REPROGRAMMED AT 5.0 V/0.75 MS, BECAUSE THE THRESHOLD INCREASED. THE SITE REPORTED ON 28 JANUARY 2020 THAT THE PATIENT DIED (EXACT DATE UNKNOWN) FROM AN INFECTION AND WAS CREMATED ON (B)(6) 2020.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT WENT TO THE EMERGENCY ON (B)(6) 2020 BECAUSE OF A CONVULSIVE SEIZURE. IT WAS NOT POSSIBLE TO INTERROGATE THE PACEMAKER WITH FOUR DIFFERENT PROGRAMMERS, THOUGH THE INDUCTIVE TELEMETRY HEAD WAS PLACED OVER THE DEVICE; NO GREEN LIGHT APPEARED. AS A RECENTLY EXPLANTED PACEMAKER COULD BE SUCCESSFULLY INTERROGATED, ELECTROMAGNETIC INTERFERENCES (EMI) WERE EXCLUDED. THE ECG SHOWED AN INTRINSIC RHYTHM AROUND 60-65 BPM THOUGH THE DEVICE WAS PROGRAMMED IN VVI MODE WITH A BASIC RATE AT 70 MIN-1. NO PACING SPIKES WERE NOTICED. WHEN A MAGNET WAS APPLIED, ABSENCE OF PACEMAKER REACTION WAS OBSERVED. THE PATIENT IS CURRENTLY HOSPITALIZED IN THE INTENSIVE CARE UNIT. DURING THE PREVIOUS FOLLOW-UP PERFORMED ON (B)(6) 2019, THE ESTIMATED RESIDUAL LONGEVITY DISPLAYED WAS 3 YEARS AND THE PACING OUTPUTS WERE REPROGRAMMED AT 5.0 V/0.75 MS, BECAUSE THE THRESHOLD INCREASED. THE SITE REPORTED ON 28 JANUARY 2020 THAT THE PATIENT DIED (EXACT DATE UNKNOWN) FROM AN INFECTION AND WAS CREMATED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122802 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY DR 2804

    Patients

    Seq Age Sex Outcome Treatment
    1 Death