MAUDE Adverse Event Report: PREVENTICE SERVICES PREVENTICE; DETECTOR AND ALARM, ARRHYTHMIA

Device Problems No Audible Alarm (1019); Failure to Transmit Record (1521)

Patient Problems Ventricular Fibrillation (2130); Asystole (4442)

Event Date 04/15/2022

Event Type  Death  

Event Description

The patient's wife called on 4/18/2022 to inform the office of the patient's unexpected passing (in his sleep).This had occurred some time between 4/15-4/16/2022.During my call back to her, we realized that he was wearing the event monitor during this time.We had not received any notification from preventice prior to this.We requested the event monitor and the initial download is dated 4/19.His terminal event was not downloaded to us, and the last event in the strip is from earlier in the day of the patient's ultimate passing.We called preventice requesting cardiac monitor strips during the dates of 04/15-04/16 2022.They then document their first notification of this terminal v fib event to us in response to the call on 4/21/2022.They sent us a strip showing ventricular fibrillation occurring on 4/15/2022 at 5:09 p.M.The patient remained in persistent ventricular fibrillation for over 10 minutes.The ventricular fibrillation event was reviewed with two electrophysiology providers.The patient had a pvc that fell on the preceding t-wave.He went into ventricular fibrillation due to this r on t phenomenon.This was the cause of pt's death.This event is concerning for two reasons: this was not caught or conveyed on or near the time of the event occurring.There is normally notification of any concerning event.We had to request twice to have the event data surrounding the time of death sent to us for review.The strip with the terminal event was not sent to us until we called them back and specifically asked for the time period between 04/15-04/16 2022.This call was made on 4/21/2022 and that is when they sent this strip and document informing any of us about this event.In addition, they also mention asystole which they never sent despite our request.Fda safety report id# (b)(4).

• Brand Name: PREVENTICE
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PREVENTICE SERVICES
• MDR Report Key: 14621015
• MDR Text Key: 293531877
• Report Number: MW5110121
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death