MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD CARELINK SMARTSYNC BASE; ANALYZER, PACEMAKER GENERATOR FUNCTION

Model Number 24970A

Device Problems Pacing Problem (1439); Capturing Problem (2891); Communication or Transmission Problem (2896); Computer Operating System Problem (2898); Output Problem (3005)

Patient Problem Cardiac Arrest (1762)

Event Date 01/30/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during an implant procedure, the mobile programmer ¿¿froze¿¿ and a sudden loss of connectivity between the programmer base and tablet was experienced.The user reports that the analyzer screen was open but unable to provide electrograms (egm) or live information.The user also reports the patient experienced asystole along with a loss of capture at rates of 60 beats per minute (bpm) and was able to capture rates of 70 bpm and above.An alternative programmer was then used to complete the procedure with no issues with pacing or maintaining capture reported.The programmer remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The analysis of the device logs was able to confirm the disconnection between the programmer base and associated tablet.The base was disconnected, without any visible reason (no restart of the programmer base according to the device logs and no base tablet noise reported).The main graphical user interface thread also stopped sending the safety ping requests (as there are evidence of the safety ping timeouts in the logs) without any logged entry the app was going to the background.This may be potential evidence of the observed ''application freeze''.The patient connector was connected via the universal serial bus (usb) cable through the programmer base at the time of the event.It appears the tablet returned to activities approximately 10 seconds later, resuming the base tablet connection back including the telemetry session.It is not clear why the base tablet connection was closed, the reason may be due to the fact the application (or whole tablet) froze for a period, which in turn caused the base tablet supervision timeout, leading to the connection loss.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: analysis of the mobile programmer base was unable to confirm the customer comment of a programmer freeze and loss of communication.The patient connector charges with a known good universal serial bus (usb) cable and remains charged for more than 24 hours with no fault found.Patient connector charges over night with base.The patient connector successfully paired via bluetooth and telemetry was successful.Analysis was unable to confirm any fault with the base station.The device was sent for further analysis.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.

Event Description

It was further reported that the programmer was returned for service.

Manufacturer Narrative

Additional analysis was conducted.Upon visual inspection no anomalies were observed.Upon benchtop analysis the device was connected to a known good ac/dc power supply.And powered up normally ¿ base power upon status led turns solid green, base station wi-fi led flashing blue, patient connector power led flashing green indicating charging and patient connector wi-fi led flashing blue.The device logs were downloaded and it was concluded there was no indication of base unit malfunction.It appears the application running on the tablet froze for unknown reasons, which is supported by the logs gathered at the time of the event.The analyzer application was launched on a tablet apple ipad and base successfully connected to the tablet ¿ base wi-fi led is solid blue.Patient connector successfully connected to the tablet ¿ patient connector wi-fi led is solid blue.Software app communicates with the base and patient connector as expected.All functions are available.A ble telemetry check using the application with an implantable device was successful.The base restarted and reconnected with the smartsync application software multiple times over a period of 24 hours.All interrogations were successful, and no abnormalities observed.The base and patient connector are operating within specification.Could not confirm customer complaint.No defect found 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.

• Brand Name: CARELINK SMARTSYNC BASE
• Type of Device: ANALYZER, PACEMAKER GENERATOR FUNCTION
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• MDR Report Key: 9746292
• MDR Text Key: 180621491
• Report Number: 3004593495-2020-00183
• Device Sequence Number: 1
• Product Code: DTC
• UDI-Device Identifier: 00763000201289
• UDI-Public: 00763000201289
• Combination Product (y/n): N
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24970A
• Device Catalogue Number: 24970A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention