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

Model Number PLATINIUM SONR CRT-D 1811

Device Problem Pacing Inadequately (1442)

Patient Problem No Information (3190)

Event Date 02/18/2021

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, during a device follow-up, several shocks episodes were found with shocks delivered at maximum energy but not effective.The impedances of all leads were within range.An important increase of right ventricular threshold was observed, from 0.75v in (b)(6) 2020 to 2.00v on (b)(6) 2021.

• 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: 11371378
• MDR Text Key: 234732029
• Report Number: 1000165971-2021-00317
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014388
• UDI-Public: (01)08031527014388(11)170207(17)180907
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2018
• Device Model Number: PLATINIUM SONR CRT-D 1811
• Device Catalogue Number: PLATINIUM SONR CRT-D 1811
• Device Lot Number: S0245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/19/2021
• Event Location: Home
• Date Manufacturer Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2017
• 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