MAUDE Adverse Event Report: MICROPORT CRM S.R.L. REPLY 200 DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number REPLY 200 DR

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 07/18/2022

Event Type  malfunction  

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.

Event Description

Reportedly, it was found that 159 pacemakers from the 200 were found to have registration certificate numbers on the product that were different from those on the outer package label and instruction manual.

Event Description

Reportedly, it was found that 159 pacemakers from the 200 were found to have registration certificate numbers on the product information (inside the box) that were different from those on the outer package label and instruction manual.

Manufacturer Narrative

Provided pictures confirmed the reported mismatch between the registration certificate numbers of the product information and the one on the outer packaging label and instruction manual.- the most probable explanation of the reported issue could be explained by an incorrect version submission of the certificate number to the supplier.- operators will be re-trained to prevent a re-occurrence of this kind of issue.- a rework was performed by introducing a clarification sheet on the certificate number in the plastic bag of the concerned products.- it should be noted that there is no patient safety risk associated to this non-conformance.

• Brand Name: REPLY 200 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: 15231279
• MDR Text Key: 304964277
• Report Number: 1000165971-2022-00356
• Device Sequence Number: 1
• Product Code: NVZ
• 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: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• 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: REPLY 200 DR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: No
• 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