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 Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 07/24/2018

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 (b)(4) that was cleared or approved by fda for marketing in the united states.

Event Description

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

Manufacturer Narrative

Preliminary analysis did not reveal any device malfunction.The electrical characteristics of the returned device conformed to established specifications.The device involved in this mdr report is not included in any recall reported to fda; field corrected.

Event Description

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

Event Description

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

• 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
• MDR Report Key: 7761808
• MDR Text Key: 116870755
• Report Number: 1000165971-2018-00725
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014524
• UDI-Public: (01)08031527014524(11)161017(17)180517
• 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,Followup
• Report Date: 09/06/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2018
• Device Model Number: PLATINIUM 4LV SONR CRT-D 1844
• Device Catalogue Number: PLATINIUM 4LV SONR CRT-D 1844
• Device Lot Number: S0231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/24/2018
• Date Manufacturer Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1