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

Model Number REPLY DR

Device Problems Labelling, Instructions for Use or Training Problem (1318); Device Markings/Labelling Problem (2911)

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

Event Date 08/15/2022

Event Type  malfunction  

Event Description

During the incoming inspection of msc warehouse, qc found that the serial numbers of the two products were confused with each other.

Event Description

During the incoming inspection of msc warehouse, qc found that the serial numbers of the two products were confused with each other.

Manufacturer Narrative

The manufacturing process review did not reveal any abnormality and the rework has been done.The issue is now resolved.

• Brand Name: REPLY DR
• 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
• MDR Report Key: 15321183
• MDR Text Key: 304297003
• Report Number: 1000165971-2022-00390
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P950029
• 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: 09/09/2022

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 DR
• Device Catalogue Number: REPLY DR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 08/15/2022
• Supplement Dates FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic