MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number PLATINIUM DR 1510

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 06/16/2020

Event Type  malfunction  

Event Description

Reportedly, during incoming inspection, the subject icd was interrogated with an orchestra plus and unexpected warning messages were displayed.

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer Contact: laura ouaki ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 146013429
• MDR Report Key: 10256537
• MDR Text Key: 198964586
• Report Number: 1000165971-2020-00497
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 08031527015378
• UDI-Public: (01)08031527015378(11)200311(17)220911
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2022
• Device Model Number: PLATINIUM DR 1510
• Device Catalogue Number: PLATINIUM DR 1510
• Device Lot Number: S0434
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/17/2020
• Event Location: Other
• Date Manufacturer Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2020
• 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