MAUDE Adverse Event Report: MICROPORT CRM S.R.L. PLATINIUM; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number PLATINIUM DR 1510

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

At this stage of the investigation, the subject device is not involved in any of our fsca.

Event Description

Simon sloan from distribution organization in ireland received 26/2/2024 from brain mcloughlin, cardiac physiologist form the bons secours hospital in dublin (e mail attached).It was communicated that the patient had deceased in 2022 but his wife had received a letter regarding a recall / field action on her husband¿s device.This caused significant distress and she call her physician immediately, dr tom gumbrielle who then contacted brain mcloughlin to investigate if the device was subject to field action.

• Brand Name: PLATINIUM
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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 ; 146013665
• MDR Report Key: 18968878
• MDR Text Key: 339050612
• Report Number: 1000165971-2024-00275
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 08031527014364
• UDI-Public: (01)08031527014364(17)150619(11)151117
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2019
• Device Model Number: PLATINIUM DR 1510
• Device Catalogue Number: TDF032C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2017
• 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
• Patient Ethnicity: Non Hispanic