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

Model Number TEO DR

Device Problem Pacing Problem (1439)

Patient Problems Syncope (1610); Syncope/Fainting (4411)

Event Date 01/17/2021

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 patient was admitted to the emergency due to two syncopal episodes.On the surface ecg, a 2:1 av block with vvi stimulation at 50 min-1 was observed.During the pacemaker check, there was loss of atrial capture in bipolar configuration and both atrial and ventricular thresholds rose.Atrial threshold test revealed lack of sensing and pacing with 2:1 av block.As pacemaker and leads malfunctions are suspected, the entire system was explanted.Preliminary analysis did not reveal any anomaly with the provided ecg, atrial loss of capture could not be confirmed; however, it revealed several episodes suspicious of intermittent ventricular loss of capture.Expertise of the returned device did not reveal any issue on the subject pacemaker.

Manufacturer Narrative

Please refer to the attached investigation report.

Event Description

Reportedly, the patient was admitted to the emergency due to two syncopal episodes.On the surface ecg, a 2:1 av block with vvi stimulation at 50 min-1 was observed.During the pacemaker check, there was loss of atrial capture in bipolar configuration and both atrial and ventricular thresholds rose.Atrial threshold test revealed lack of sensing and pacing with 2:1 av block.As pacemaker and leads malfunctions are suspected, the entire system was explanted.

• 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
• MDR Report Key: 11348537
• MDR Text Key: 239775392
• Report Number: 1000165971-2021-00299
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527017204
• UDI-Public: (01)08031527017204(11)200619(17)220619
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2022
• Device Model Number: TEO DR
• Device Catalogue Number: TEO DR
• Device Lot Number: S0453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/26/2021
• Date Manufacturer Received: 07/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1