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

Model Number PARADYM RF SONR CRT-D 9770

Device Problem Telemetry Discrepancy (1629)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2014

Event Type  malfunction  

Event Description

Reportedly, the subject device was replaced two years after implantation because it showed lack of communication (no green leds turned on on the programmer head) and no answer to magnet application.The device will be returned for analysis.

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, the subject device was replaced two years after implantation because it showed lack of communication (no green leds turned on the programmer head) and no answer to magnet application.The device will be returned for analysis.

• Brand Name: PARADYM
• 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 9214 0; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; parc d'affaires noveos 4 avenue réaumur; .; clamart 9214 0; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 4285940
• MDR Text Key: 5056928
• Report Number: 1000165971-2014-00666
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2014

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: 10/13/2012
• Device Model Number: PARADYM RF SONR CRT-D 9770
• Device Catalogue Number: PARADYM RF SONR CRT-D 9770
• Device Lot Number: 2560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/07/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 12/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2011
• 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