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

Model Number ESPRIT D

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 11/13/2020

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 sorin that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, the subject pacemaker was implanted on (b)(6) 2020.After the implantation, it was observed that, in the box of the pacemaker, the small labels (stickers) containing the model and serial number of the pacemaker used to fill the implant registration form were missing, only bigger labels were available.

Event Description

Reportedly, the subject pacemaker was implanted on (b)(6) 2020.After the implantation, it was observed that, in the box of the pacemaker, the small labels (stickers) containing the model and serial number of the pacemaker used to fill the implant registration form were missing, only bigger labels were available.

Manufacturer Narrative

Please refer to the attached analysis report.

• 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
• MDR Report Key: 10987473
• MDR Text Key: 221565060
• Report Number: 1000165971-2020-00792
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 08031527009070
• UDI-Public: (01)08031527009070(11)190911(17)210411
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

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: 04/11/2021
• 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: 11/17/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 02/15/2021
• Supplement Dates FDA Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1