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 Low impedance (2285)

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

Event Date 08/22/2014

Event Type  malfunction  

Event Description

Low impedance of the atrial lead (sorin brand) was reportedly observed on the home monitoring report of (b)(4) 2014.The icd, the atrial lead and the defibrillation lead were explanted on (b)(6) 2014.

Event Description

Low impedance of the atrial lead (sorin brand) was reportedly observed on the home monitoring report of (b)(6) 2014.The icd, the atrial lead and the defibrillation lead were explanted on (b)(6) 2014.

Event Description

Low impedance of the atrial lead (sorin brand) was reportedly observed on the home monitoring report of (b)(6) 2014.The icd, the atrial lead and the defibrillation lead were explanted on (b)(6) 2014.

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.

Manufacturer Narrative

Preliminary analysis revealed the presence of noise and/or artifacts in atrial and ventricular channels in several episodes recorded in (b)(6) 2014.

• 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: 4093263
• MDR Text Key: 4718726
• Report Number: 1000165971-2014-00531
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Paramedic
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2014

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: 08/05/2013
• Device Model Number: PARADYM RF SONR CRT-D 9770
• Device Catalogue Number: PARADYM RF SONR CRT-D 9770
• Device Lot Number: 2632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/22/2014
• Initial Date Manufacturer Received: 11/18/2014
• Initial Date FDA Received: 09/16/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/05/2014; 11/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2012
• 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