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 Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

Pending.The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by (b)(4) that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, the device was prophylactically replaced since the patient was pacing-dependent, as advised in the fsn on platinium devices sent in (b)(6) 2018.

Event Description

Reportedly, the device was prophylactically replaced since the patient was pacing-dependent, as advised in the fsn on platinium devices sent in (b)(6) 2018.

Manufacturer Narrative

The device involved in this mdr report is not included in any recall reported to fda.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: 7762222
• MDR Text Key: 116875238
• Report Number: 1000165971-2018-00732
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/11/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2018
• Device Model Number: PLATINIUM SONR CRT-D 1811
• Device Catalogue Number: PLATINIUM SONR CRT-D 1811
• Device Lot Number: S0216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/31/2018
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 08/15/2018
• Supplement Dates FDA Received: 09/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1