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

Model Number TEO SR

Device Problem Missing Test Results (3267)

Patient Problem No Information (3190)

Event Date 10/16/2019

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, on (b)(6) 2019, during a follow-up after the implantation of the subject device, tests were performed but the impedance, threshold and detection tests values were missing in the printout; however, these data were properly displayed on the screen.On (b)(6) 2019, when checking the recorded interrogation files, it was suspected that the aforementioned data were not saved.The tests were performed manually and the event occurred with two orchestra programmers.

Event Description

Reportedly, during the follow-up after the implantation of the subject device on (b)(6) 2019, lead measurements were performed manually, but the r-waves amplitude value was not displayed on the overview screen.On (b)(6) 2019, when checking the recorded interrogation files with two different programmers, it was suspected that the value was not saved.

Manufacturer Narrative

Please refer to the attached analysis report.- attachment: [20200311 - file-2019-04036 - analysis_and_closure_report_resp-2020-00230.Pdf].

Manufacturer Narrative

B3 was modified: the correct event date is (b)(6) 2019.B5 was corrected.

Event Description

Reportedly, during the follow-up after the implantation of the subject device on (b)(6) 2019, lead measurements were performed manually, but the r-waves amplitude value was not displayed on the overview screen.On (b)(6) 2019, when checking the recorded interrogation files with two different programmers, it was suspected that the value was not saved.

• 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: 9433613
• MDR Text Key: 177379645
• Report Number: 1000165971-2019-00676
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527017211
• UDI-Public: (01)08031527017211(11)190228(17)210228
• 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,Followup
• Report Date: 03/11/2020

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: 02/28/2021
• Device Model Number: TEO SR
• Device Catalogue Number: TEO SR
• Device Lot Number: S0355
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/15/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 01/03/2020; 02/18/2020
• Supplement Dates FDA Received: 01/27/2020; 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1