MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, RESYNCHRONIZATION (CRT-D)

Model Number PARADYM SONR CRT-D TRI-V

Device Problem Over-Sensing (1438)

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

Event Date 10/15/2020

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 a follow-up performed on (b)(6) 2021, three non-sustained episodes showing noise oversensing were observed.According to the patient, no activity was performed that could have generated this noise, and the noise was not reproduced during maneuvers.A re-intervention is reportedly scheduled on (b)(6) 2021.

• Brand Name: PARADYM
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, RESYNCHRONIZATION (CRT-D)
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; via crescentino s.n.; .; saluggia (vc) 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; via crescentino s.n.; .; saluggia (vc) 13040 ; IT 13040
• Manufacturer Contact: laura ouaki ; via crescentino s.n.; .; saluggia (vc) 13040 ; IT 13040 ; 146013429
• MDR Report Key: 11309040
• MDR Text Key: 232533704
• Report Number: 1000165971-2021-00272
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2015
• Device Model Number: PARADYM SONR CRT-D TRI-V
• Device Catalogue Number: PARADYM SONR CRT-D TRI-V
• Device Lot Number: 2822
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/16/2021
• Date Manufacturer Received: 01/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2014
• 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