MAUDE Adverse Event Report: MICROPORT CRM S.R.L. TEO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number TEO DR

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)

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

Event Date 02/15/2024

Event Type  malfunction  

Event Description

Reportedly, during the procedure of a ventricular lead replacement, the atrial lead was disconnected as well from the pacemaker.The physician did not succeed to reconnect the atrial lead to the current pacemaker while the new ventricular lead was well connected.The physician decided to use another pacemaker.

Manufacturer Narrative

The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, during the procedure of a ventricular lead replacement, the atrial lead was disconnected as well from the pacemaker.The physician did not succeed to reconnect the atrial lead to the current pacemaker while the new ventricular lead was well connected.The physician decided to use another pacemaker.

Manufacturer Narrative

The conclusions are as follows: the visual inspection did not reveal any abnormality.The analysis confirms that the connection system of the subject pacemaker functioned as specified using a duplicate torque-limiting screwdriver.The atrial and the ventricular setscrews were found completely unscrewed.It is known that when they are unscrewed, it can be difficult to screw them again.This observation can explain the issue reported in this complaint at the atrial level.Based on the available data, no issue is suspected on the subject pacemaker.For more details, please refer to the attached analysis report.

• Brand Name: TEO
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 18934126
• MDR Text Key: 338070075
• Report Number: 1000165971-2024-00246
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/21/2024

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: TEO DR
• Device Catalogue Number: TEO DR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic