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 Delayed Charge Time (2586); Wireless Communication Problem (3283)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

The device model 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, a charge time of 15.8s was recorded during tests, and it was not possible to switch to rf connection with the inductive telemetry head placed over the device.The battery voltage was at 3.16v and a residual longevity of 9 years was displayed.A second charging test was performed and a charge time of 12.3s was measured.

Event Description

Reportedly, a charge time of 15.8s was recorded during tests, and it was not possible to switch to rf connection with the inductive telemetry head placed over the device.The battery voltage was at 3.16v and a residual longevity of 9 years was displayed.A second charging test was performed and a charge time of 12.3s was measured.

Manufacturer Narrative

Expertise of the returned device did not reveal any anomaly.Electrical characteristics of the returned device were within specifications.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, a charge time of 15.8s was recorded during tests, and it was not possible to switch to rf connection with the inductive telemetry head placed over the device.The battery voltage was at 3.16v and a residual longevity of 9 years was displayed.A second charging test was performed and a charge time of 12.3s was measured.

• 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: 9932199
• MDR Text Key: 187528245
• Report Number: 1000165971-2020-00344
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014388
• UDI-Public: (01)08031527014388(11)190117(17)200817
• 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: 08/25/2020

1 Device was Involved in the Event

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: 08/17/2020
• Device Model Number: PLATINIUM SONR CRT-D 1811
• Device Catalogue Number: PLATINIUM SONR CRT-D 1811
• Device Lot Number: S0349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/12/2020
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/07/2020
• Supplement Dates Manufacturer Received: 04/17/2020; 07/30/2020
• Supplement Dates FDA Received: 04/28/2020; 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1