MAUDE Adverse Event Report: MICROPORT CRM S.R.L. SMARTTOUCH; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number SMARTTOUCH SOFTWARES MODULES

Device Problem Wireless Communication Problem (3283)

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

Event Date 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

Review of the provided files revealed : - several devices were interrogated since august 2023.Bluetooth or inductive communications were used.- in the log files, several observations of communication errors have been made (on different days, with different devices and different type of communication) - the origin of these communication errors cannot be determined with certainty, it is probably due to disturbances in the environment.Disturbances can be due to a electrical noise source close to the implant or to the head such as screens, chargers, another inductive head.Based on available data, no issue is suspected on the device.

Event Description

Reportedly, an error occurred at interrogation, it happens regularly.

Manufacturer Narrative

Upon reception, the returned smarttouch tablet was tested, and the reported behavior was not reproduced, as normal functioning was observed.Review of the provided files revealed : - several devices were interrogated since august 2023.Bluetooth or inductive communications were used.- in the log files, several observations of communication errors have been made (on different days, with different devices and different type of communication) - the origin of these communication errors cannot be determined with certainty, it is probably due to disturbances in the environment.Disturbances can be due to a electrical noise source close to the implant or to the head such as screens, chargers, another inductive head.Based on available data, no issue is suspected on the device.

Event Description

Reportedly, an error occurred at interrogation, it happens regularly.

• Brand Name: SMARTTOUCH
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• 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: 19022975
• MDR Text Key: 339153702
• Report Number: 1000165971-2024-00293
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 08031527021003
• UDI-Public: (01)08031527021003
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: TPR003C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 05/06/2024
• 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