MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION

Model Number PLATINIUM SONR CRT-D 1811

Device Problems Over-Sensing (1438); Unexpected Therapeutic Results (1631)

Patient Problems Shock (2072); Ventricular Fibrillation (2130)

Event Date 08/19/2019

Event Type  malfunction  

Manufacturer Narrative

The device model involved in this mdr is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, 7 ineffective shocks at 42 joules were delivered to treat a ventricular fibrillation.The patient was hospitalized in emergency.

Manufacturer Narrative

(device code) corrected.

Event Description

Reportedly, 7 ineffective shocks at 42 joules were delivered to treat a ventricular fibrillation.The patient was hospitalized in emergency.

Event Description

Reportedly, 7 ineffective shocks at 42 joules were delivered to treat a ventricular fibrillation.The patient was hospitalized in emergency.

Manufacturer Narrative

(first name, last name, email address, phone number) corrected.Based on preliminary analysis, no issue is suspected on the subject crt-d.

Manufacturer Narrative

Please refer to the updated analysis report.

Event Description

Reportedly, 7 ineffective shocks at 42 joules were delivered to treat a ventricular fibrillation.The patient was hospitalized in emergency.

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION
• 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: 8991080
• MDR Text Key: 159750970
• Report Number: 1000165971-2019-00535
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014388
• UDI-Public: (01)08031527014388(11)161124(17)180624
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2018
• Device Model Number: PLATINIUM SONR CRT-D 1811
• Device Catalogue Number: PLATINIUM SONR CRT-D 1811
• Device Lot Number: S0236
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/20/2019
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1