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

Model Number	PARADYM RF DR 9550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly, the subject icd was explanted with leads due to due to complications.It was mentioned also 'defective lead'.The subject icd will be returned for analysis.
Additional Manufacturer Narrative
We were informed that finally they inactivated the entire system but the device and a-leads are still active.
Event or Problem Description
Reportedly, the subject icd was explanted with leads due to due to complications.It was mentioned also 'defective lead'.The subject icd will be returned for analysis.
Additional Manufacturer Narrative
Please refer to the attached analysis report.
Event or Problem Description
Reportedly, the subject icd was explanted with leads due to due to complications.It was mentioned also 'defective lead'.The subject icd will be returned for analysis.

• Brand Name: PARADYM RF
• Common Device Name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; 4 avenue réaumur; parc d'affaires noveos; clamart, 92140 ; FR 92140
• MDR Report Key: 6519045
• Report Number: 1000165971-2017-00347
• Device Sequence Number: 1292683
• Product Code: MRM
• UDI-Device Identifier: 08031527012254
• UDI-Public: (01)08031527012254(11)161006(17)161106
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P060027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/06/2016
• Device Model Number: PARADYM RF DR 9550
• Device Catalogue Number: PARADYM RF DR 9550
• Device Lot Number: S0117
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/04/2017
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: Not provided; 10/11/2017
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 05/22/2017; 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention