MAUDE Adverse Event Report: MICROPORT CRM S.R.L. SMARTTOUCH SOFTWARE MODULES; PROGRAMMER, PACEMAKER

Model Number SMARTTOUCH SOFTWARES MODULES

Device Problem Wireless Communication Problem (3283)

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

Event Date 01/08/2024

Event Type  malfunction  

Event Description

Reportedly, following upgrade to smartview 3.14 version, with the ble correctly activated, it was impossible to interrogate an alizea pacemaker using ble communication and only inductive communication was possible.The same situation was observed after restarting the tablet.

Event Description

Reportedly, following upgrade to smartview 3.14 version, with the ble correctly activated, it was impossible to interrogate an alizea pacemaker using ble communication and only inductive communication was possible.The same situation was observed after restarting the tablet.

Manufacturer Narrative

Analysis synthesis: upon reception, the returned smarttouch tablet was tested, and the reported behavior was confirmed, as bluetooth communication was not available.- in-depth analysis revealed that the bluetooth adapter was unexpectedly deactivated, which led to the observed difficulties to use ble communication with an alizea pacemaker.- the correction embedded in smartview 3.14 version prevented the occurrence of this issue several times.However, it seems that a particular non-covered case occurred.Additional tests should be performed to better understand the event.- the subject smarttouch tablet will follow the repair workflow and will be sent back to the field.

• Brand Name: SMARTTOUCH SOFTWARE MODULES
• Type of Device: PROGRAMMER, PACEMAKER
• 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: 18629550
• MDR Text Key: 334418960
• Report Number: 1000165971-2024-00091
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMARTTOUCH SOFTWARES MODULES
• Device Catalogue Number: SMARTTOUCH SOFTWARES MODULES
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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