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

Model Number PLATINIUM 4LV SONR CRT-D 1844

Device Problem Over-Sensing (1438)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2020

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, during a follow-up performed on (b)(6) 2020, an episode showing ventricular noise oversensing was recorded on (b)(6) 2020 at 12:44, which triggered the charging of the capacitors.The patient does not report any activity that could have caused an interference.No maneuvers were performed to determine if the noise was reproducible.

• Brand Name: PLATINIUM
• 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: laura ouaki ; via crescentino s.n.; saluggia (vc) 13040 ; IT 13040 ; 146013429
• MDR Report Key: 11309170
• MDR Text Key: 232535646
• Report Number: 1000165971-2021-00273
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014524
• UDI-Public: (01)08031527014524(11)170718(17)190218
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2019
• Device Model Number: PLATINIUM 4LV SONR CRT-D 1844
• Device Catalogue Number: PLATINIUM 4LV SONR CRT-D 1844
• Device Lot Number: S0273
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/15/2021
• Date Manufacturer Received: 01/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2017
• 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