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

Model Number PLATINIUM SONR CRT-D 1811

Device Problem Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

The device model involved in this mdr 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

On (b)(6) 2020, the subject device was opened in addition to the implanted one, as sensing errors occurred that could not allow the device to function correctly (sensing of the r wave oscillated from 0.8 to 1 with some peaks of 15.4).A different programmer gave similar values, and using a pacing system analyzer (psa) provided excellent sensing values.The subject device was then opened, but the problem also occurred with this device.The suspected cause was that the device was detecting the start of the qrs complex and blanking the rest of the complex, which was always visible even if not perceived in both devices.The first device was implanted after increasing sensitivity from 0.4 mv to 0.8 mv, which solved the issue.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

On (b)(6) 2020, the subject device was opened in addition to the implanted one, as sensing errors occurred that could not allow the device to function correctly (sensing of the r wave oscillated from 0.8 to 1 with some peaks of 15.4).A different programmer gave similar values, and using a pacing system analyzer (psa) provided excellent sensing values.Another device was then opened, but the problem also occurred with this device.The suspected cause was that the device was detecting the start of the qrs complex and blanking the rest of the complex, which was always visible even if not perceived in both devices.The first device was implanted after increasing sensitivity from 0.4 mv to 0.8 mv, which solved the issue.

• 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
• Manufacturer (Section G): MICROPORT CRM S.R.L.; via crescentino s.n.; .; saluggia (vc), 13040 ; IT 13040
• Manufacturer Contact: elodie vincent ; via crescentino s.n.; .; saluggia (vc), 13040 ; IT 13040 ; 146013429
• MDR Report Key: 11177521
• MDR Text Key: 228618092
• Report Number: 1000165971-2021-00229
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014388
• UDI-Public: (01)08031527014388(11)200721(17)230121
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

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: 01/21/2023
• Device Model Number: PLATINIUM SONR CRT-D 1811
• Device Catalogue Number: PLATINIUM SONR CRT-D 1811
• Device Lot Number: S0459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/22/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 10/27/2021
• Supplement Dates FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1