MAUDE Adverse Event Report: MICROPORT CRM S.R.L. PLATINIUM; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number PLATINIUM 4LV SONR CRT-D 1844

Device Problems Migration or Expulsion of Device (1395); Expulsion (2933)

Patient Problem Twiddlers Syndrome (4563)

Event Date 12/06/2023

Event Type  malfunction  

Event Description

The patient came to the hospital with a clear evidence of pocket decubitus.No fever or other symptoms.The patient was sent back home and a total extraction is scheduled for (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

The conclusions are as follows: - the subject devices were sterilized and released according to applicable standard operating procedures.- despite the can deformation observed at reception, it should be noted that the returned device showed normal operation.This deformation probably occurred while the device was outside the body or during the explantation procedure.- based on the available data, no issue is suspected on the subject pacemaker.- the complaint has been recorded for trending purposes.

Event Description

The patient came to the hospital with a clear evidence of pocket decubitus.No fever or other symptoms.The patient was sent back home and a total extraction is scheduled for (b)(6) 2023.

• Brand Name: PLATINIUM
• 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: 18442971
• MDR Text Key: 331926819
• Report Number: 1000165971-2024-00013
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2023
• Device Model Number: PLATINIUM 4LV SONR CRT-D 1844
• Device Catalogue Number: TDF040C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2021
• 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