MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number PARADYM RF DR 9550

Device Problem Issue With Displayed Error Message (2967)

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

Event Date 02/20/2018

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 sorin that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, during a follow-up performed on (b)(6) 2018, a warning message stating "[a10] ventricular lead impedance < 200 ohms: (b)(6) 2047, 3 day min criterion.Defibrillation system potentially ineffective" was displayed on the programmer screen.Threshold, sensing and leads impedance tests were performed and the results were within normal range.

Event Description

Reportedly, during a follow-up performed on (b)(6) 2018, a warning message stating "[a10] ventricular lead impedance less than 200 ohms: 18/may/2047, 3 day min criterion.Defibrillation system potentially ineffective" was displayed on the programmer screen.Threshold, sensing and leads impedance tests were performed and the results were within normal range.

Manufacturer Narrative

(b)(4).

• Brand Name: PARADYM RF
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• MDR Report Key: 7344596
• MDR Text Key: 102853195
• Report Number: 1000165971-2018-00265
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• PMA/PMN Number: P060027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2014
• Device Model Number: PARADYM RF DR 9550
• Device Catalogue Number: PARADYM RF DR 9550
• Device Lot Number: 2700
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/20/2018
• Event Location: Hospital
• Date Manufacturer Received: 03/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1