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

Model Number REPLY 200 DR

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  malfunction  

Event Description

Reportedly, in the packaging, the patient identification card was missing.The packaging has been reworked.

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

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 microport crm that was cleared or approved by fda for marketing in the united states.Analysis synthesis: reportedly, the patient identification card was missing from the packaging box of a pacemaker.Review of the manufacturing records associated to the packaging operation of the subject device revealed that the device was packaged and released following all applicable procedures.The absence of the patient identification card was most likely due to human error, the operator forgetting to insert the card into the packaging box.Corrective actions to reduce the event's recurrence are currently under implementation.

Event Description

Reportedly, in the packaging, the patient identification card was missing.The packaging has been reworked.

• 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: elodie vincent ; via crescentino s.n; saluggia (vc) 13040 ; IT 13040 ; 146013665
• MDR Report Key: 18417478
• MDR Text Key: 331602523
• Report Number: 1000165971-2023-01078
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 08031527012360
• UDI-Public: (01)08031527012360(17)080925(11)080923
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

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 Model Number: REPLY 200 DR
• Device Catalogue Number: TPM003E
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2023
• 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
• Patient Ethnicity: Non Hispanic