MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number PARADYM SONR CRT-D 8770

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Atrial Fibrillation (1729); Tachycardia (2095)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

The device model 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, on (b)(6) 2019, the patient was hospitalized due to suspicious of previously untreated ventricular tachycardias (vt).The device was interrogated and 12 episodes were found; only one dated (b)(6) 2019 was classified as vt with a therapy delivered.The episodes dated (b)(6) 2019 were classified as supraventricular tachycardia (svt); consequently, no therapy was delivered.No ventricular undersensing was observed and the device was programmed in parad+ (stability+/acceleration) despite an atrial fibrillation was occurring in the same time.Preliminary analysis revealed that the device behaved within specifications and according to the programmed parameters.

Event Description

Reportedly, on (b)(6) 2019, the patient was hospitalized due to suspicious of previously untreated ventricular tachycardias (vt).The device was interrogated and 12 episodes were found; only one dated (b)(6) 2019 was classified as vt with a therapy delivered.The episodes dated (b)(6) 2019 were classified as supraventricular tachycardia (svt); consequently, no therapy was delivered.No ventricular undersensing was observed and the device was programmed in parad+ despite an atrial fibrillation was occurring in the same time.The device was reprogrammed in stability+/acceleration on (b)(6) 2019.Preliminary analysis revealed that the device behaved within specifications and according to the programmed parameters.

• Brand Name: PARADYM
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• 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: 9384471
• MDR Text Key: 177201868
• Report Number: 1000165971-2019-00654
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

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: 03/19/2015
• Device Model Number: PARADYM SONR CRT-D 8770
• Device Catalogue Number: PARADYM SONR CRT-D 8770
• Device Lot Number: 2802
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/04/2019
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1