MAUDE Adverse Event Report: MICROPORT CRM S.R.L. PLATINIUM; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number PLATINIUM 4LV SONR CRT-D 1844

Device Problems Pacemaker Found in Back-Up Mode (1440); Communication or Transmission Problem (2896)

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

Event Date 06/03/2021

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 was in nominal mode (vvi 60 with only the fv therapy zone at 190 bpm), but no alerts were received through the remote monitoring system.

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• 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: 12118477
• MDR Text Key: 259978685
• Report Number: 1000165971-2021-00541
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014524
• UDI-Public: (01)08031527014524(11)200212(17)210912
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2021
• Device Model Number: PLATINIUM 4LV SONR CRT-D 1844
• Device Catalogue Number: PLATINIUM 4LV SONR CRT-D 1844
• Device Lot Number: S0429
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2020
• 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