MAUDE Adverse Event Report: MICROPORT CRM S.R.L. ALIZEA; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number ALIZEA SR 1300

Device Problem Inappropriate or Unexpected Reset (2959)

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

Event Date 03/28/2023

Event Type  malfunction  

Event Description

Reportedly, a re-intervention of placement for alizea sr was performed due to normal battery depletion of reply sr on (b)(6) 2023.A warning 27 (warning: '27' device has been reinitialized twice by bos) message was confirmed at the pre-discharge check on (b)(6) 2023 (occurence date on (b)(6) 2023).

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

Correction : h6 health effect impact code.

Event Description

Reportedly, a re-intervention of placement for (b)(6) was performed due to normal battery depletion of reply sr on (b)(6) 2023.A warning 27 (warning: '27' device has been reinitialized twice by bos) message was confirmed at the pre-discharge check on (b)(6) 2023 (occurence date (b)(6) 2023).

• Brand Name: ALIZEA
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 16776142
• MDR Text Key: 313843572
• Report Number: 1000165971-2023-00345
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

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: ALIZEA SR 1300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 04/20/2023
• 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