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

Model Number SMARTTOUCH TABLET

Device Problem Wireless Communication Problem (3283)

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

Event Date 07/26/2023

Event Type  malfunction  

Event Description

Reportedly, during two implantations on (b)(6) 2023 bluetooth communication problems with the pacemakers were observed.

Manufacturer Narrative

Investigation outcome: ¿ analysis of the provided expertise files confirmed the reported behavior, as four failed attempts to establish bluetooth communication were observed on 26 july 2023.¿ in-depth analysis revealed that the observed issue resulted from an unexpected error at the level of the bluetooth adapter, which could not be reset correctly as the timeout was reached.As a result, the programmer was not able to initialize bluetooth communication.¿ further investigations are ongoing to determine the root-cause of bluetooth communication issues and to implement corrective actions if necessary.¿ the subject smarttouch tablet will follow the normal repair workflow and will be sent back to the field.

Event Description

Reportedly, during two implantations on (b)(6) 2023 bluetooth communication problems with the pacemakers were observed.

Manufacturer Narrative

Updated conclusion after returned device investigation: ¿ analysis of the provided expertise files confirmed the reported behavior, as four failed attempts to establish bluetooth communication were observed on (b)(6) 2023.¿ in-depth analysis revealed that the observed issue resulted from an unexpected error at the level of the bluetooth adapter, which could not be reset correctly as the timeout was reached.As a result, the programmer was not able to initialize bluetooth communication.¿ upon reception of the returned tablet, the reported behavior could not be confirmed.¿ neither any freeze could be reproduced nor any ble communication failed.The tablet connected to both a reference pacemaker and bluetooth printer without any problem.¿ the subject smarttouch tablet followed the normal repair workflow (including a re-ghost to restore its initial configuration) and will be sent back to the field.¿ this case is retained and utilized for trend purposes.

Event Description

Reportedly, during two implantations on (b)(6) 2023 bluetooth communication problems with the pacemakers were observed.

• Brand Name: SMARTTOUCH
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MANUFACTURED FOR MICROPORT CRM S.R.L.; parc d'affaires noveos; 4 avenue reaumur; clamart 92140 ; FR 92140
• 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: 17539227
• MDR Text Key: 321079263
• Report Number: 1000165971-2023-00614
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMARTTOUCH TABLET
• Device Catalogue 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: 10/27/2023
• 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