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

Model Number	PARADYM RF VR 9250
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportedly, during a follow-up performed on (b)(6) 2018, a sudden increase in the ventricular lead impedance curve, up to 3000 ohms, was observed around (b)(6) 2018.The ventricular lead impedance measurements decreased in (b)(6) 2018 and were within normal range during the follow-up performed on (b)(6) 2018.
Event or Problem Description
Reportedly, during a follow-up performed on (b)(6) 2018, a sudden increase in the ventricular lead impedance curve, up to 3000 ohms, was observed around (b)(6) 2018.The ventricular lead impedance measurements decreased in (b)(6) 2018 and were within normal range during the follow-up performed on (b)(6) 2018.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: PARADYM RF
• Common Device Name: 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: 7395862
• Report Number: 1000165971-2018-00331
• Device Sequence Number: 1470814
• Product Code: MRM
• UDI-Device Identifier: 08031527013916
• UDI-Public: (01)08031527013916(11)150407(17)160507
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P060027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/07/2016
• Device Model Number: PARADYM RF VR 9250
• Device Catalogue Number: PARADYM RF VR 9250
• Device Lot Number: S0074
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/14/2018
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1