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

Model Number ULYS DF4 DR - 2540

Device Problems Device Displays Incorrect Message (2591); Erratic Results (4059)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2022

Event Type  malfunction  

Event Description

Reportedly, the rv continuity coil was noted under 200 ohm (in red)s on 2 remote reports (on (b)(6) 2022 and on (b)(6) 2022).However, coils are indicated "ok" in the front page of the report and the rv continuity coil curve is stable in normal range.

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.

Manufacturer Narrative

Analysis of the provided expertise files confirmed the reported event: the rv coil continuity was indicated to be lower than 200 ohms in the remote reports dated on (b)(6)2022.However, it was observed that the rv coil continuity measurement stored in the device memory was in fact 346 ohms on (b)(6) 2022.In-depth analysis revealed that the observed mismatch between the measured value and the displayed value resulted from a software anomaly, which occurred under specific conditions, leading to the storage of the programmed amplitude parameter in the device statistics instead of the measured amplitude.Therefore, the calculation of the last rv coil continuity value was made with the wrong amplitude value and the result obtained was therefore wrong, thus explaining why ¿< 200 ohms¿ was displayed in the remote report.It should be noted that the rv coil continuity curve displayed the correct impedance value.The correct impedance value on (b)(6) 2022 is 346 ohms (normal range).Corrective actions of this software issue are currently being contemplated.

Event Description

Reportedly, the rv continuity coil was noted under 200 ohms (in red) on 2 remote reports (on (b)(6) 2022).However, coils are indicated "ok" in the front page of the report and the rv continuity coil curve is stable in normal range.Reports seem incoherent on this subject.

• Brand Name: ULYS DF4 DR - 2540
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM DEFIBRILLATOR, IMPLANTABLE, DUAL-CH
• 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: 15050148
• MDR Text Key: 304377518
• Report Number: 1000165971-2022-00330
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2022
• 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