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

Model Number PLATINIUM 4LV SONR CRT-D 1844

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 03/18/2022

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, atrial events and markers are present on the svt episodes despite parad+ and 'atrial monitoring' being deactivated.

Event Description

Reportably, atrial events and markers are present on the svt episodes despite parad+ and 'atrial monitoring' being deactivated.

Manufacturer Narrative

No expertise files nor additional information were provided for analysis and the subject device was not returned.As a result, no investigation could be performed and the root-cause of the reported behavior could not be determined.Based on the available data, the most likely hypothesis is that the strips containing the as and parad+ markers correspond to aida recordings that were taken at a time that the device was programmed differently.It should be noted that apparently aida had not been reset for quite a while, so it is perfectly possible the device was still having strips in its memory from a time where the device was programmed differently.

• Brand Name: PLATINIUM 4LV SONR CRT-D 1844
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• 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: 14100746
• MDR Text Key: 289170772
• Report Number: 1000165971-2022-00169
• 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: 06/14/2022

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: PLATINIUM 4LV SONR CRT-D 1844
• Device Catalogue 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
• Distributor Facility Aware Date: 03/18/2022
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 03/18/2022
• Supplement Dates FDA Received: 06/14/2022
• 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