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

Model Number PLATINIUM SONR CRT-D 1811

Device Problems Inadequate Instructions for Healthcare Professional (1319); Unexpected Therapeutic Results (1631)

Patient Problems Arrhythmia (1721); Atrial Tachycardia (1731); Low Blood Pressure/ Hypotension (1914); Dizziness (2194)

Event Date 12/01/2020

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.

Event Description

Reportedly, during the implantation procedure, the patient went into sinus tachycardia at 160-170 min-1.The physician wanted to use the overdrive feature in order to control the atrial arrhythmia, but he was informed that this feature was not available in the subject device.The patient then had a drop in blood pressure and was complaining of dizziness.Preliminary analysis results confirmed that the overdrive feature is not available for this device model in (b)(6), in compliance with the specifications applicable in (b)(6).However, analysis revealed that this function is mistakenly mentioned in the associated labeling.

Manufacturer Narrative

The overdrive feature mistakenly mentioned in the labeling is a feature that aims at preventing an atrial arrhythmia.Based on the event description, the physician wanted to control an atrial arrhythmia, which means that he was looking for another type of atrial overdrive feature (nips type), by design not included in the subject crt-d.

Event Description

Reportedly, during the implantation procedure, the patient went into sinus tachycardia at 160-170 min-1.The physician wanted to use the overdrive feature in order to control the atrial arrhythmia, but he was informed that this feature was not available in the subject device.The patient then had a drop in blood pressure and was complaining of dizziness.Preliminary analysis results confirmed that the overdrive feature is not available for this device model in canada, in compliance with the specifications applicable in canada.However, analysis revealed that this function is mistakenly mentioned in the associated labeling.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, during the implantation procedure, the patient went into sinus tachycardia at 160-170 min-1.The physician wanted to use the overdrive feature in order to control the atrial arrhythmia, but he was informed that this feature was not available in the subject device.The patient then had a drop in blood pressure and was complaining of dizziness.Preliminary analysis results confirmed that the overdrive feature is not available for this device model in canada, in compliance with the specifications applicable in canada.However, analysis revealed that this function is mistakenly mentioned in the associated labeling.

• 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: 11072213
• MDR Text Key: 224563179
• Report Number: 1000165971-2020-00843
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527015552
• UDI-Public: (01)08031527015552(11)200630(17)221230
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2022
• Device Model Number: PLATINIUM SONR CRT-D 1811
• Device Catalogue Number: PLATINIUM SONR CRT-D 1811
• Device Lot Number: S0454
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/01/2020
• Event Location: Hospital
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1