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

Model Number TEO DR

Device Problems Pacing Problem (1439); Pacing Inadequately (1442); Use of Device Problem (1670); Device Handling Problem (3265)

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

Event Date 05/31/2022

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

Pacemaker is programmed to auto implantation detection and active to bipolar.With the changing of the leads the pacemaker was not able to stimulate outside the body.Just unipolar.The patient became a flat line.Before i was telling the doctor that the pacemaker is stimulating uni and bipolar.But it did not work bipolar.I thought the problem that was already known is now changed but it's not.

Manufacturer Narrative

Please refer to the analysis report attached.

Event Description

Pacemaker is programmed to auto implantation detection and active to bipolar.With the changing of the leads the pacemaker was not able to stimulate outside the body.Just unipolar.The patient became a flat line.Before i was telling the doctor that the pacemaker is stimulating uni and bipolar.But it did not work bipolar.It was a pacemaker replacement with old leads which are both bipolar.

• Brand Name: TEO DR
• 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: 14879346
• MDR Text Key: 303256479
• Report Number: 1000165971-2022-00293
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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