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

Model Number ESPRIT SR

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 10/27/2020

Event Type  malfunction  

Event Description

Reportedly, during an incoming inspection it was noted that the orange carton box of the subject pacemaker was damaged.At reception, the external carton box in which the orange one was located was found damaged.

Event Description

Reportedly, during an incoming inspection it was noted that the orange carton box of the subject pacemaker was damaged.At reception, the external carton box in which the orange one was located was found damaged.

Manufacturer Narrative

Review of the device manufacturing records showed no irregularity.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, during an incoming inspection it was noted that the orange carton box of the subject pacemaker was damaged.At reception, the external carton box in which the orange one was located was found damaged.

• 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: 10835721
• MDR Text Key: 217696424
• Report Number: 1000165971-2020-00723
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 08031527009155
• UDI-Public: (01)08031527009155(11)200911(17)220411
• Combination Product (y/n): N
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2021

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: Other
• Device Expiration Date: 04/11/2022
• Device Model Number: ESPRIT SR
• Device Catalogue Number: ESPRIT SR
• Device Lot Number: S0462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/27/2020
• Event Location: Other
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 11/27/2020; 12/23/2020
• Supplement Dates FDA Received: 12/14/2020; 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1