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

Model Number PLATINIUM VR 1210

Device Problem Over-Sensing (1438)

Patient Problems Cardiopulmonary Arrest (1765); Heart Failure (2206)

Event Date 07/17/2018

Event Type  Injury  

Event Description

Reportedly, the patient implanted with the subject icd was hospitalized on (b)(6) 2018 due to heart failure.On (b)(6) 2018, the patient suffered from a cardiorespiratory arrest in hospital room.The subject icd was interrogated after 10 min of cardio-pulmonary resuscitation but no ventricular arrhythmia episode was stored in the device memory.Reportedly, this serious adverse event is considered as not device-related.Preliminary analysis did not reveal any anomaly on the subject device.

Event Description

Reportedly, the patient implanted with the subject icd was hospitalized on (b)(6) 2018 due to heart failure.On (b)(6) 2018 , the patient suffered from a cardiorespiratory arrest in hospital room.The subject icd was interrogated after 10 min of cardio-pulmonary resuscitation but no ventricular arrhythmia episode was stored in the device memory.Reportedly, this serious adverse event is considered as not device-related.Preliminary analysis did not reveal any anomaly on the subject device.

Manufacturer Narrative

Please refer to the attached analysis report.Attachment: [20190716 - file-2019-01068 - analysis_and_closure_report_resp-2019-00539.Pdf].

• 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: 8486282
• MDR Text Key: 141010353
• Report Number: 1000165971-2019-00197
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 08031527014357
• UDI-Public: (01)08031527014357(11)151006(17)170506
• 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,study
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2017
• Device Model Number: PLATINIUM VR 1210
• Device Catalogue Number: PLATINIUM VR 1210
• Device Lot Number: S0116
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/15/2019
• Date Manufacturer Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1