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

Model Number ULYS DF4 DR - 2540

Device Problem Low impedance (2285)

Patient Problem Insufficient Information (4580)

Event Date 07/25/2022

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.Preliminary analysis revealed that the reported issue most probably resulted from a software anomaly.

Event Description

Reportedly, the coil impedance is lower than 200 ohms.Preliminary analysis revealed that the reported issue most probably resulted from a software anomaly.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, the rv coil impedance is lower than 200 ohms.

• Brand Name: ULYS
• 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: 15266211
• MDR Text Key: 304964187
• Report Number: 1000165971-2022-00379
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2022
• 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
• Patient Ethnicity: Non Hispanic