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

Model Number PLATINIUM 4LV SONR CRT-D 1844

Device Problems High impedance (1291); Device Sensing Problem (2917); No Pacing (3268)

Patient Problem No Information (3190)

Event Date 04/16/2019

Event Type  malfunction  

Manufacturer Narrative

The device involved in this mdr report 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, after a rf ablation performed on (b)(6) 2019, loss of pacing was observed on the ecg.Upon crt-d interrogation on (b)(6) 2019, all the leads impedances were abnormal.Loss of sensing and pacing was also observed.According to the physician, the recommendations included in the implant manual regarding ablation were appropriately followed.

Manufacturer Narrative

Preliminary analysis revealed that, due to a wrong software management under specific conditions, the device entered a blocked state, resulting in absence of pacing and sensing.

Event Description

Reportedly, after a rf ablation performed on (b)(6) 2019, loss of pacing was observed on the ecg.Upon crt-d interrogation on 17 april 2019, all the leads impedances were abnormal.Loss of sensing and pacing was also observed.According to the physician, the recommendations included in the implant manual regarding ablation were appropriately followed.

Event Description

Reportedly, after a rf ablation performed on (b)(6)2019 , loss of pacing was observed on the ecg.Upon crt-d interrogation on (b)(6)2019 , all the leads impedances were abnormal.Loss of sensing and pacing was also observed.According to the physician, the recommendations included in the implant manual regarding ablation were appropriately followed.

Manufacturer Narrative

Please refer to the attached analysis report.

• 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: 8603136
• MDR Text Key: 144971089
• Report Number: 1000165971-2019-00289
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014524
• UDI-Public: (01)08031527014524(11)180716(17)200216
• 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
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2020
• Device Model Number: PLATINIUM 4LV SONR CRT-D 1844
• Device Catalogue Number: PLATINIUM 4LV SONR CRT-D 1844
• Device Lot Number: S0329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/17/2019
• Event Location: Hospital
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1