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

Model Number PARADYM RF SONR CRT-D 9770

Device Problem Over-Sensing (1438)

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

Event Date 12/09/2015

Event Type  malfunction  

Manufacturer Narrative

The device model involved in this mdr is not approved in the u.S.; however it is similar to paradym rf crt-d 9750 models.

Event Description

During the routine follow-up, several tachycardia and fibrillation episodes were observed.The majority of these episodes were due to the presence of noise in the ventricular channel.No inappropriate therapies were delivered.

Event Description

During the routine follow-up, several tachycardia and fibrillation episodes were observed.The majority of these episodes were due to the presence of noise in the ventricular channel.No inappropriate therapies were delivered.

• Brand Name: PARADYM RF
• 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
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 5318466
• MDR Text Key: 34764083
• Report Number: 1000165971-2015-00785
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2015

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: 12/03/2012
• Device Model Number: PARADYM RF SONR CRT-D 9770
• Device Catalogue Number: PARADYM RF SONR CRT-D 9770
• Device Lot Number: 2582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/09/2015
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2011
• 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