MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF; DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)

Model Number	PARADYM RF CRT-D 9750
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	06/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the subject device presented a reset warning message dated (b)(6) 2018 and parameters had been reprogrammed to vvi mode at 60 bpm with a vf zone at 190 bpm.Reportedly, follow-up testing was performed with no abnormalities observed and the device was re-programmed successfully to the pre-reset parameters.A charge time test did not reveal any irregularity.The patient has recently complained of chest pain and has come to the emergency room several times complaining of a tingling in their chest.
Event or Problem Description
It was reported that the subject device presented a reset warning message dated (b)(6) 2018 and parameters had been reprogrammed to vvi mode at 60 bpm with a vf zone at 190 bpm.Reportedly, follow-up testing was performed with no abnormalities observed and the device was re-programmed successfully to the pre-reset parameters.A charge time test did not reveal any irregularity.The patient has recently complained of chest pain and has come to the emergency room several times complaining of a tingling in their chest.
Additional Manufacturer Narrative
Please refer to the attached analysis report.

• Brand Name: PARADYM RF
• Common Device Name: 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
• MDR Report Key: 7595229
• Report Number: 1000165971-2018-00558
• Device Sequence Number: 144228
• Product Code: NIK
• UDI-Device Identifier: 08031527012278
• UDI-Public: (01)08031527012278(11)160309(17)170409
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2018

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: 04/09/2017
• Device Model Number: PARADYM RF CRT-D 9750
• Device Catalogue Number: PARADYM RF CRT-D 9750
• Device Lot Number: S0158
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/11/2018
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 09/27/2018
• 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