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

Model Number PLATINIUM 4LV SONR CRT-D 1844

Device Problem Wireless Communication Problem (3283)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2020

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, before the implantation procedure, the subject crt-d was attempted to be interrogated with a orchestra plus programmer, but the rf communication with the orchestra+ link was not possible.The programmer was beeping as expected to allow withdrawal of the inductive programming head and after doing that the message displaying that there was no rf communication was observed.The box of the device was turned trying to find a better position for the rf communication with the orchestra+ link, moving the device away and moving the orchestra+ link away from the programmer, but still the rf communication was not possible.Then, it was attempted again with a smarttouch programmer and with another orchestra+ link, but there was still no rf communication.Finally, another platinium crtd sonr 1844 was used with good rf communication and no problems with the orchestra+ and finally implanted successfully.After the procedure, another attempt was made, without success.

Event Description

On (b)(6) 2020, before the implantation procedure, the subject crt-d was attempted to be interrogated with a orchestra plus programmer, but the rf communication with the orchestra+ link was not possible.The programmer was beeping as expected to allow withdrawal of the inductive programming head and after doing that the message displaying that there was no rf communication was observed.The box of the device was turned trying to find a better position for the rf communication with the orchestra+ link, moving the device away and moving the orchestra+ link away from the programmer, but still the rf communication was not possible.Then, it was attempted again with a smarttouch programmer and with another orchestra+ link, but there was still no rf communication.Finally, another platinium crtd sonr 1844 was used with good rf communication and no problems with the orchestra+ and finally implanted successfully.After the procedure, another attempt was made, without success.

• 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: 11035968
• MDR Text Key: 227487563
• Report Number: 1000165971-2020-00815
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014524
• UDI-Public: (01)08031527014524(11)190716(17)210216
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2021
• Device Model Number: PLATINIUM 4LV SONR CRT-D 1844
• Device Catalogue Number: PLATINIUM 4LV SONR CRT-D 1844
• Device Lot Number: S0393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/25/2020
• Event Location: Hospital
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1