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

Model Number ESPRIT DR

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 11/06/2021

Event Type  malfunction  

Event Description

Reportedly, during incoming inspection, it was observed that the labels of fifty-six devices were blurred and unreadable.

Event Description

Reportedly, during incoming inspection, it was observed that the labels of fifty-six devices were blurred and unreadable.

• 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
• MDR Report Key: 12924402
• MDR Text Key: 281735472
• Report Number: 1000165971-2021-01538
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

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: Health Professional
• Device Model Number: ESPRIT DR
• Device Catalogue Number: ESPRIT DR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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