MAUDE Adverse Event Report: MICROPORT CRM S.R.L. SMARTTOUCH; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS

Model Number SMARTTOUCH TABLET

Device Problems Computer Software Problem (1112); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/25/2023

Event Type  malfunction  

Event Description

Reportedly, smarttouch screen did not respond and froze during tests.After new interrogation no iegm markers were visible in the real time iegm on the overview screen (see photo enclosed).Restarting the device did not solve the problem.

Event Description

Reportedly, smarttouch screen did not respond and froze during tests.After new interrogation no iegm markers were visible in the real time iegm on the overview screen (see photo enclosed).Restarting the device did not solve the problem.

Manufacturer Narrative

Upon reception, the subject smarttouch tablet was tested and the reported behavior was not reproduced.- no freeze occurred when using aida or egm function - the egm/marker signal on the top of the screen appears normally with ble communication (alizea device was used for the test) and with rf communication (platinium device was used for the test) - as explained in the intermediate response, the reported small markers on the top of the screen are most probably related to disturbances caused by nearby appliances/objects during the bluetooth communication.- no anomaly is suspected on the subject smarttouch tablet.

• Brand Name: SMARTTOUCH
• Type of Device: PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n.; saluggia, vc 13040 ; IT 13040
• Manufacturer (Section G): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer Contact: elodie vincent ; via crescentino s.n; saluggia (vc) 13040 ; IT 13040 ; 146013665
• MDR Report Key: 17612758
• MDR Text Key: 321848987
• Report Number: 1000165971-2023-00646
• Device Sequence Number: 1
• Product Code: OSR
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMARTTOUCH TABLET
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic