MAUDE Adverse Event Report: MICROPORT CRM S.R.L. ULYS DF4 DR - 2540; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number ULYS DF4 DR - 2540

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2022

Event Type  malfunction  

Event Description

The remote monitoring transmission from (b)(6)2022 showed a rv coil continuity below 200 ohms.Therefore the reporter deviced to call in the patient to the hospital.The in-clinic follow up on (b)(6)2022with the smarttouch-tablet showed normal rv coil continuity values and trend.No alert in the programmer interogation.The reporter asks for clarification of this discepancy.

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 remote monitoring transmission from 24/oct/2022 showed a rv coil continuity below 200 ohms.Therefore the reporter deviced to call in the patient to the hospital.The in-clinic follow up on 25/oct/2022 with the smarttouch-tablet showed normal rv coil continuity values and trend.No alert in the programmer interogation.The reporter asks for clarification of this discepancy.

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.Please refer to the attached analysis report.

• Brand Name: ULYS DF4 DR - 2540
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• 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
• MDR Report Key: 15853242
• MDR Text Key: 304985592
• Report Number: 1000165971-2022-00536
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULYS DF4 DR - 2540
• Device Catalogue Number: ULYS DF4 DR - 2540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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