MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM 2; DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)

Model Number PARADYM 2 CRT-D 8752

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2019

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 sorin that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, the icd was interrogated before being explanted.Since right ventricular sensing amplitude was low, a 30 hz induction test was performed to test the device.At the beginning of the test, egms were visible on the screen, but later on no egm nor markers were displayed.Only the small ecg at the top of the programmer screen and the scope allowed to observe that the patient was in ventricular fibrillation, received a 42j shock and returned to sinus rhythm.Nothing was displayed on the screen even after the shock.However, an episode was recorded (with egms and markers) in the device memory.

Event Description

Reportedly, the icd was interrogated before being explanted.Since right ventricular sensing amplitude was low, a 30 hz induction test was performed to test the device.At the beginning of the test, egms were visible on the screen, but later on no egm nor markers were displayed.Only the small ecg at the top of the programmer screen and the scope allowed to observe that the patient was in ventricular fibrillation, received a 42j shock and returned to sinus rhythm.Nothing was displayed on the screen even after the shock.However, an episode was recorded (with egms and markers) in the device memory.

• Brand Name: PARADYM 2
• Type of Device: DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• MDR Report Key: 8481593
• MDR Text Key: 143977369
• Report Number: 1000165971-2019-00188
• Device Sequence Number: 1
• Product Code: NIK
• 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
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2015
• Device Model Number: PARADYM 2 CRT-D 8752
• Device Catalogue Number: PARADYM 2 CRT-D 8752
• Device Lot Number: 2825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/13/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 04/24/2019
• Supplement Dates FDA Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1