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

Model Number TEO DR

Device Problem Missing Test Results (3267)

Patient Problem No Information (3190)

Event Date 01/10/2019

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 sorin that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, twenty minutes after pacemaker implantation, and during a manual sensing test (device programmed in ddi mode at 30 min-1), the amplitude of atrial sensed events was not displayed.Moreover, no message about auto-initialization phase was observed.After reboot of the programmer, a new interrogation was performed and normal atrial sensing was observed during a new sensing test.

Manufacturer Narrative

Please refer to the attached analysis report.- attachment: [20190320 - file-2019-00114 - analysis_and_closure_report_resp-2019-00351.Pdf].

Event Description

Reportedly, twenty minutes after pacemaker implantation, and during a manual sensing test (device programmed in ddi mode at 30 min-1), the amplitude of atrial sensed events was not displayed.Moreover, no message about auto-initialization phase was observed.After reboot of the programmer, a new interrogation was performed and normal atrial sensing was observed during a new sensing test.

• Brand Name: TEO
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): MICROPORT CRM S.R.L.; parc d'affaires noveos 4 avenue reaumur; clamart 92140 ; FR 92140
• MDR Report Key: 8296501
• MDR Text Key: 134878053
• Report Number: 1000165971-2019-00058
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527017204
• UDI-Public: (01)08031527017204(11)181011(17)201011
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

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 Expiration Date: 10/11/2020
• Device Model Number: TEO DR
• Device Catalogue Number: TEO DR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/10/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 02/01/2019
• Supplement Dates Manufacturer Received: 03/01/2019
• Supplement Dates FDA Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1