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

Model Number ESPRIT SR

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 10/20/2020

Event Type  malfunction  

Event Description

Reportedly, during incoming inspection, the text printed on the outer label of the packaging box was found unclear.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, during incoming inspection, the text printed on the outer label of the packaging box was found unclear.

• 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: 10835602
• MDR Text Key: 217696704
• Report Number: 1000165971-2020-00720
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 08031527009155
• UDI-Public: (01)08031527009155(11)200827(17)220327
• Combination Product (y/n): N
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

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: 03/27/2022
• Device Model Number: ESPRIT SR
• Device Catalogue Number: ESPRIT SR
• Device Lot Number: S0459
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/20/2020
• Event Location: Other
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1