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

Model Number ENO DR

Device Problem Battery Problem: High Impedance (2947)

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

Event Date 01/20/2021

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, the subject pacemaker was implanted on (b)(6) 2021.On (b)(6) 2021, it was observed that the battery impedance was 1.42 kohms.During a later interrogation performed on (b)(6) 2021, a value of 0.21 kohms was measured.Preliminary analysis results showed that the observed temporary variation of the battery impedance was most probably due to the transition between room temperature and body temperature.No anomaly is suspected on the pacemaker.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, the subject pacemaker was implanted on (b)(6) 2021.On (b)(6) 2021, it was observed that the battery impedance was 1.42 kohms.During a later interrogation performed on (b)(6) 2021, a value of 0.21 kohms was measured.Preliminary analysis results showed that the observed temporary variation of the battery impedance was most probably due to the transition between room temperature and body temperature.No anomaly is suspected on the pacemaker.

• 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: 11328033
• MDR Text Key: 233744431
• Report Number: 1000165971-2021-00292
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527017181
• UDI-Public: (01)08031527017181(11)200622(17)220622
• 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: 06/22/2021

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: 06/22/2022
• Device Model Number: ENO DR
• Device Catalogue Number: ENO DR
• Device Lot Number: S0454
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/20/2021
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/15/2021
• Supplement Dates Manufacturer Received: 06/02/2021
• Supplement Dates FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1