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

Model Number ENO SR

Device Problem Pacing Intermittently (1443)

Patient Problem Weakness (2145)

Event Date 08/13/2020

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, after the implantation of the subject pacemaker on (b)(6) 2020, the physician was not able to interrogate the device with a smarttouch tablet due to telemetry issues.Interrogation with an orchestra plus programmer was performed; pacing and sensing parameters were ok but when the physician tried to modified the basic rate, spontaneous rhythm at 20 bpm without pacing was observed on the ecg until the basic rate was changed to 60 bpm.The physician estimated that the absence of pacing lasted approximately a minute and this occurred twice.Following this event, sensing and pacing threshold tests were performed as well as a fluoroscopy that confirmed the correct position of the ventricular lead.Preliminary analysis did not reveal any anomaly with the subject pacemaker.

Manufacturer Narrative

Preliminary analysis of the provided files could not confirm the reported intermittent absence of pacing.All electrical lead measurements and tests performed revealed regular values.

Event Description

Reportedly, after the implantation of the subject pacemaker on (b)(6) 2020, the physician was not able to interrogate the device with a smarttouch tablet due to telemetry issues.Interrogation with an orchestra plus programmer was performed; pacing and sensing parameters were ok but when the physician tried to modified the basic rate, spontaneous rhythm at 20 bpm without pacing was observed on the ecg until the basic rate was changed to 60 bpm.The physician estimated that the absence of pacing lasted approximately a minute and this occurred twice.Following this event, sensing and pacing threshold tests were performed as well as a fluoroscopy that confirmed the correct position of the ventricular lead.Preliminary analysis did not reveal any anomaly with the subject pacemaker.

Event Description

Reportedly, after the implantation of the subject pacemaker on (b)(6) 2020, the physician was not able to interrogate the device with a smarttouch tablet due to telemetry issues.Interrogation with an orchestra plus programmer was performed; pacing and sensing parameters were ok but when the physician tried to modified the basic rate, spontaneous rhythm at 20 bpm without pacing was observed on the ecg until the basic rate was changed to 60 bpm.The physician estimated that the absence of pacing lasted approximately a minute and this occurred twice.Following this event, sensing and pacing threshold tests were performed as well as a fluoroscopy that confirmed the correct position of the ventricular lead.Preliminary analysis did not reveal any anomaly with the subject pacemaker.

Manufacturer Narrative

Please refer to the attached analysis report.

• Brand Name: ENO
• 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: 10489093
• MDR Text Key: 206749097
• Report Number: 1000165971-2020-00589
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527017198
• UDI-Public: (01)08031527017198(11)200505(17)220505
• 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: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2022
• Device Model Number: ENO SR
• Device Catalogue Number: ENO SR
• Device Lot Number: S0445
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/14/2020
• Event Location: Hospital
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1