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 CRT-D 8750

Device Problem High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2017

Event Type  Injury  

Event Description

Reportedly, the right ventricular lead impedance was slowly getting higher and higher while the coil continuity was decreasing.The physician would like to know if the lead should be replaced.Preliminary analysis showed that a gradual lead issue or a gradual physiological phenomenon occurring at the implant site could be at the origin of the reported behavior, but the root cause remains unexplained.

Manufacturer Narrative

Date of event corrected.

Event Description

Reportedly, the right ventricular lead impedance was slowly getting higher and higher while the coil continuity was decreasing.The physician would like to know if the lead should be replaced.Preliminary analysis showed that a gradual lead issue or a gradual physiological phenomenon occurring at the implant site could be at the origin of the reported behavior, but the root cause remains unexplained.

• 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 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: 7145874
• MDR Text Key: 95753927
• Report Number: 1000165971-2017-00958
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P060027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2013
• Device Model Number: PARADYM CRT-D 8750
• Device Catalogue Number: PARADYM CRT-D 8750
• Device Lot Number: 2605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/07/2017
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 02/08/2018
• Supplement Dates FDA Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2012
• 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
• Patient Outcome(s): Required Intervention