MAUDE Adverse Event Report: MICROPORT CRM S.R.L. REPLY; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number ESPRIT D

Device Problem Battery Problem: High Impedance (2947)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

The device model involved in this mdr 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

The pacemaker was implanted on (b)(6) 2021, and the programmer showed that the internal resistance of the battery was very high (6.63kohm) this occurred in the northeast of china where the temperature is below 0.

• Brand Name: REPLY
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: laura ouaki ; via crescentino s.n.; .; saluggia (vc) 13040 ; IT 13040 ; 146013429
• MDR Report Key: 11299786
• MDR Text Key: 233743668
• Report Number: 1000165971-2021-00267
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 08031527009070
• UDI-Public: (01)08031527009070(11)190910(17)210410
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/09/2021

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: 04/10/2021
• Device Model Number: ESPRIT D
• Device Catalogue Number: ESPRIT D
• Device Lot Number: S0398
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/15/2021
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2019
• 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