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

Model Number PLATINIUM DR 1540

Device Problems Incorrect Measurement (1383); Failure to Transmit Record (1521)

Patient Problem No Information (3190)

Event Date 09/05/2018

Event Type  malfunction  

Event Description

Reportedly, on (b)(6) 2018, the follow-up center of the patient received an alert relative to atp therapy delivery.It was observed on the remote report that the displayed statistics for atrial pacing was superior to 100 %.The associated programmer source file was reviewed and the percentage of atrial pacing was 92%.On (b)(6) 2018, the patient called the center to report symptoms.A remote report transmission was initiated by the patient and the delivery of an atp therapy was observed.However, the center did not receive any alert relative to this atp.

Manufacturer Narrative

Please refer to the attached analysis report.- attachment: [20190109 - file-2018-03189 - analysis_and_closure_report_resp-2019-00028.Pdf].

Event Description

Reportedly, on (b)(6) 2018, the follow-up center of the patient received an alert relative to atp therapy delivery.It was observed on the remote report that the displayed statistics for atrial pacing was superior to 100 %.The associated programmer source file was reviewed and the percentage of atrial pacing was 92%.On 7 september 2018, the patient called the center to report symptoms.A remote report transmission was initiated by the patient and the delivery of an atp therapy was observed.However, the center did not receive any alert relative to this atp.

• 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
• MDR Report Key: 8003958
• MDR Text Key: 125110072
• Report Number: 1000165971-2018-00946
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 08031527014388
• UDI-Public: (01)08031527014388(11)161014(17)180514
• Combination Product (y/n): N
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2018
• Device Model Number: PLATINIUM DR 1540
• Device Catalogue Number: PLATINIUM DR 1540
• Device Lot Number: S0223
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/02/2018
• Event Location: Hospital
• Date Manufacturer Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1