MAUDE Adverse Event Report: MICROPORT CRM S.R.L. PLATINIUM; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION

Model Number PLATINIUM SONR CRT-D 1841

Device Problems Over-Sensing (1438); Pacing Intermittently (1443)

Patient Problems No Information (3190); Insufficient Information (4580)

Event Date 10/07/2020

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 microport crm that was cleared or approved by fda for marketing in the united states.

Event Description

The subject crt-d was implanted as a replacement device on (b)(6) 2018, and connected to already implanted atrial and ventricular leads.The patient is pacing-dependent.Reportedly, during a follow-up performed on (b)(6) 2021, several episodes recorded in the device memory until (b)(6) 2020 showed ventricular noise oversensing, leading to ventricular pacing inhibition.No inappropriate therapy was delivered as a result of the oversensing.The patient did not report any symptoms.Capture threshold, lead impedance and detection values were within normal range.The physician decided to schedule a re-intervention to replace the right ventricular lead, as a lead issue was suspected.On (b)(6) 2021, the right ventricular lead was abandoned in patient¿s body and replaced.Preliminary analysis revealed that the observed noise could have resulted from electromagnetic interferences (emi) and/or myopotentials.Nevertheless, the beginning of a ventricular lead issue could not be excluded with certainty.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

The subject crt-d was implanted as a replacement device on (b)(6) 2018, and connected to already implanted atrial and ventricular leads.The patient is pacing-dependent.Reportedly, during a follow-up performed on (b)(6) 2021, several episodes recorded in the device memory until (b)(6) 2020 showed ventricular noise oversensing, leading to ventricular pacing inhibition.No inappropriate therapy was delivered as a result of the oversensing.The patient did not report any symptoms.Capture threshold, lead impedance and detection values were within normal range.The physician decided to schedule a re-intervention to replace the right ventricular lead, as a lead issue was suspected.On (b)(6) 2021, the right ventricular lead was abandoned in patient's body and replaced.Preliminary analysis revealed that the observed noise could have resulted from electromagnetic interferences (emi) and/or myopotentials.Nevertheless, the beginning of a ventricular lead issue could not be excluded with certainty.

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n.; .; saluggia (vc), 13040 ; IT 13040
• MDR Report Key: 11273931
• MDR Text Key: 233742706
• Report Number: 1000165971-2021-00258
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014425
• UDI-Public: (01)08031527014425(11)180221(17)190921
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2019
• Device Model Number: PLATINIUM SONR CRT-D 1841
• Device Catalogue Number: PLATINIUM SONR CRT-D 1841
• Device Lot Number: S0306
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/12/2021
• Event Location: Hospital
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1