MAUDE Adverse Event Report: MICROPORT CRM S.R.L. PLATINIUM 4LV SONR CRT-D 1844; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION

Model Number PLATINIUM 4LV SONR CRT-D 1844

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Chest Pain (1776)

Event Date 01/05/2022

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, the device delivered an inappropriate shock to the patient.

Manufacturer Narrative

Review of the episodes recorded in the device memory showed (last data files dated of (b)(6) 2022) that 3 shock therapies were recorded in (b)(6) 2022).One shock therapy was delivered on fv (05 january), and 2 shock therapies were delivered for a fast ventricular rhythm that was first classified as a svt/st episodes (b)(6) 2022).- the most probable hypothesis to explain the discrimination of an atrial fibrillation as a ventricular tachycardia is that long cycles were not detected as the programmed long cycle gap was too long.- based on available data, the crt-d operated as programmed and as specified.No issue is suspected on the subject crt-d.

Event Description

A shock was reported as inappropriate.

• Brand Name: PLATINIUM 4LV SONR CRT-D 1844
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION
• 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: 15238954
• MDR Text Key: 298132011
• Report Number: 1000165971-2022-00364
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PLATINIUM 4LV SONR CRT-D 1844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2022
• 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