MAUDE Adverse Event Report: MICROPORT CRM S.R.L. PLATINIUM 4LV CRT-D 1744; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER,WITH CRT-D

Model Number PLATINIUM 4LV CRT-D 1744

Device Problems Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Atrial Flutter (1730); Electric Shock (2554)

Event Date 03/11/2022

Event Type  malfunction  

Event Description

Reportedly, the device delivered 2 atp therapies on atrial flutter episode (detected as slow vt).Following second atp, the patient rhythm was accelerated to vf (vflutter) and shock was delivered by the device : ventricular rhythm was converted.

Manufacturer Narrative

Analysis of the episodes dated on (b)(6) 2022 revealed a fast ventricular rhythm on the ventricular channel.The ventricular rate exceeded the vt cut-off rate.However, these fast ventricular rhythms were most probably the result of an underlying of the initial atrial flutter (about 400 min-1), with variable conduction ratio (2:1 or 3:1) to the ventricles.The stability was reached without associated pr nor long cycle.Therefore the ventricular rhythm was classified as ventricular tachycardia.As expected in the vt zone, atp was applied after the persistence was reached.The delivery of atp might have induced a fast ventricular tachycardia, and a vf majority was reached, leading to a shock delivery.Based on available data, normal functioning of the device occurred.No anomaly is suspected on the subject: (b)(4).

Event Description

Reportedly, the device delivered 2 atp therapies on atrial flutter episode (detected as slow vt).Following second atp, rhythm was accelerated to vf (vflutter) and shock was delivered.Ventricular rhythm was converted; atrial rhythm continued in atrial flutter.

• Brand Name: PLATINIUM 4LV CRT-D 1744
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER,WITH CRT-D
• 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: 14687038
• MDR Text Key: 302399556
• Report Number: 1000165971-2022-00277
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060027
• 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: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PLATINIUM 4LV CRT-D 1744
• Device Catalogue Number: PLATINIUM 4LV CRT-D 1744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2022
• 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