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

Model Number PLATINIUM DR 1510

Device Problem Failure to Transmit Record (1521)

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

Event Date 05/05/2020

Event Type  malfunction  

Event Description

Reportedly, the subject platinium dr was associated to an home monitor (with serial number (b)(4) that has not sent an alert after the delivery of a shock on (b)(6) 2020, even though "all shocks" alert was activated.On (b)(6) 2020, the device was interrogated by inductive telemetry and it was confirmed the delivery of the shock on (b)(6) 2020.A patient initiated transfer transmission was then performed, to check the proper communication between the subject device and the home monitor.

• 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: 10148260
• MDR Text Key: 195435227
• Report Number: 1000165971-2020-00426
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 08031527014364
• UDI-Public: (01)08031527014364(11)180409(17)191109
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2019
• Device Model Number: PLATINIUM DR 1510
• Device Catalogue Number: PLATINIUM DR 1510
• Device Lot Number: S0311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/21/2020
• Event Location: Hospital
• Date Manufacturer Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2018
• 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