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

Model Number SMARTTOUCH SOFTWARE MODULES

Device Problem Wireless Communication Problem (3283)

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

Event Date 07/03/2023

Event Type  malfunction  

Event Description

Reportedly, the bluetooth communication was intermittent with an alizea pacemaker.

Event Description

Reportedly, the bluetooth communication was intermittent with an alizea pacemaker.

Manufacturer Narrative

Please refer to the attached analysis report.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.- it should be noted that a correction of this software issue has been implemented in smartview 3.14.- the subject smarttouch tablet will follow the repair workflow (including an installation of smartview 3.14) 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
• MDR Report Key: 17442452
• MDR Text Key: 320224324
• Report Number: 1000165971-2023-00572
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMARTTOUCH SOFTWARE MODULES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2023
• 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