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

Model Number ENO DR

Device Problem Interrogation Problem (4017)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2020

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 and approved by fda for marketing in the united states.

Event Description

Reportedly, an unexpected message was observed upon interrogation with a smarttouch programmer.It was observed that the patient presented a large scar hematoma, which resulted in three or four green leds out of five lit on top of the inductive programming head upon interrogation.The device was properly functioning.The device could be successfully interrogated with an orchestra plus programmer a few days later.

Event Description

Reportedly, an unexpected message was observed upon interrogation with a smarttouch programmer.It was observed that the patient presented a large scar hematoma, which resulted in three or four green leds out of five lit on top of the inductive programming head upon interrogation.The device was properly functioning.The device could be successfully interrogated with an orchestra plus programmer a few days later.

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: 11088351
• MDR Text Key: 226650241
• Report Number: 1000165971-2020-00860
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527017181
• UDI-Public: (01)08031527017181(11)201001(17)221001
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: ENO DR
• Device Catalogue Number: ENO DR
• Device Lot Number: S0466
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/10/2020
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1