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

Model Number TEO DR

Device Problems Failure to Capture (1081); Pacing Problem (1439); Connection Problem (2900)

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

Event Date 01/24/2024

Event Type  malfunction  

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, the physician tried inserting the right ventricular lead into the port and then tightening the screw.The turning was successful and the physician heard a limiting crackle of the torque screwdriver, but the lead had no contact with the pacemaker, so there was no capture and the patient had no output.Then quickly turned back the screwdriver, removed the lead from the header and reconnected the right ventricular lead to the pacing system analyzer.The patient had a no capture again.Before a third attempt, the physician first turned the screw fully clockwise until i heard a limiting stall.Then turned back completely counterclockwise.Checked the header opening for any obstruction and verified that no screw was visible.Requested pacemaker technician who confirmed that pacemaker was indeed set to bipolar.A second physician also tried the procedure but he had the same problem of non-capture.We then decided together to get a new device and there were no problems with it and the right ventricular lead worked well immediately when connected.

Event Description

Reportedly, the physician tried inserting the right ventricular lead into the port and then tightening the screw.The turning was successful and the physician heard a limiting crackle of the torque screwdriver, but the lead had no contact with the pacemaker, so there was no capture and the patient had no output.Then quickly turned back the screwdriver, removed the lead from the header and reconnected the right ventricular lead to the pacing system analyzer.The patient had a no capture again.Before a third attempt, the physician first turned the screw fully clockwise until i heard a limiting stall.Then turned back completely counterclockwise.Checked the header opening for any obstruction and verified that no screw was visible.Requested pacemaker technician who confirmed that pacemaker was indeed set to bipolar.A second physician also tried the procedure but he had the same problem of non-capture.We then decided together to get a new device and there were no problems with it and the right ventricular lead worked well immediately when connected.Update dated of (b)(6) 2024: after the device replacement, the technician has changed the ventricular setscrew to test it and it was successful.Therefore, the original setscrew cannot be provided to analyze and to find the root cause.

Manufacturer Narrative

The conclusions are as follows: - the electrical characteristics of the returned device conformed to established specifications.Upon reception of the device, pacing pulses were generated appropriately by the device.- 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.- a piece of silicon has been noticed inside the ventricular cavity.This observation could explain why the lead was not completely inserted (in case it was present during the implantation procedure).Indeed, due to this silicon piece inside the cavity, it could be difficult to screw correctly the setscrew leading to a lead connection issue and the electrical issue described in the complaint.Nevertheless, since the original ventricular setscrew has been replaced and tested, the tightening marks of the previous one cannot be verified (correct/incorrect).- based on the available data, no issue is suspected on the subject pacemaker.

• 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
• MDR Report Key: 18774845
• MDR Text Key: 337080914
• Report Number: 1000165971-2024-00171
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527017204
• UDI-Public: (01)08031527017204(17)220925(11)220923
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03/26/2024

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: TPM016C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/25/2024
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2023
• 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