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

Model Number	REPLY DR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly, the pacing system was explanted and replaced due to infection.
Additional Manufacturer Narrative
Please refer to analysis report.
Event or Problem Description
Reportedly, the pacing system was explanted and replaced due to infection.

• Brand Name: REPLY
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc), 13040 ; IT 13040
• MDR Report Key: 11856408
• Report Number: 1000165971-2021-00456
• Device Sequence Number: 3854579
• Product Code: NVZ
• UDI-Device Identifier: 08031527011523
• UDI-Public: (01)08031527011523(11)170913(17)190413
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P950029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2019
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: S0282
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention