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

Device Problems Device Operates Differently Than Expected (2913); Inappropriate or Unexpected Reset (2959)

Patient Problem Chest Pain (1776)

Event Date 06/03/2018

Event Type  Injury  

Event 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 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.

Manufacturer Narrative

Please refer to the attached analysis report.

• Brand Name: PARADYM RF
• 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
• MDR Report Key: 7595229
• MDR Text Key: 110860064
• Report Number: 1000165971-2018-00558
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527012278
• UDI-Public: (01)08031527012278(11)160309(17)170409
• Combination Product (y/n): N
• PMA/PMN Number: P060027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 09/18/2018
• Supplement Dates FDA Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention