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 Codes	Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/23/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The defibrillation system was implanted on (b)(6) 2015.Reportedly, therapies were delivered so the patient went to the hospital on (b)(6) 2019 for a review, which revealed noise oversensing.The electrode was checked with fluoroscopy and no damage was observed.The physician decided to deactivate atp and shock therapies to monitor the patient.A follow-up was scheduled for (b)(6) 2020.On (b)(6) 2020, the defibrillation system was explanted and should be returned for analysis.During the procedure, it was not possible to explant the lead by using a stylet and retracting the helix.Therefore, the lead was explanted using another system.The physician reported that the damage on the external coil was due to the extraction maneuvers, however the filament on the proximal coil was not caused by the procedure.Preliminary analysis revealed that the noise oversensing was most probably due to a ventricular lead issue.
Additional Manufacturer Narrative
Please refer to the attached analysis report.- attachment: [20200322 - file-2019-04407 - analysis_and_closure_report_resp-2020-00313.Pdf].
Event or Problem Description
The defibrillation system was implanted on (b)(6) 2015.Reportedly, therapies were delivered so the patient went to the hospital on (b)(6) 2019 for a review, which revealed noise oversensing.The electrode was checked with fluoroscopy and no damage was observed.The physician decided to deactivate atp and shock therapies to monitor the patient.A follow-up was scheduled for (b)(6) 2020.On (b)(6) 2020, the defibrillation system was explanted and should be returned for analysis.During the procedure, it was not possible to explant the lead by using a stylet and retracting the helix.Therefore, the lead was explanted using another system.The physician reported that the damage on the external coil was due to the extraction maneuvers, however the filament on the proximal coil was not caused by the procedure.Preliminary analysis revealed that the noise oversensing was most probably due to a ventricular lead issue.
Event or Problem Description
The defibrillation system was implanted on (b)(6)2015.Reportedly, therapies were delivered so the patient went to the hospital on (b)(6)2019 for a review, which revealed noise oversensing.The electrode was checked with fluoroscopy and no damage was observed.The physician decided to deactivate atp and shock therapies to monitor the patient.A follow-up was scheduled for (b)(6)2020.On (b)(6)2020 , the defibrillation system was explanted and should be returned for analysis.During the procedure, it was not possible to explant the lead by using a stylet and retracting the helix.Therefore, the lead was explanted using another system.The physician reported that the damage on the external coil was due to the extraction maneuvers, however the filament on the proximal coil was not caused by the procedure.Preliminary analysis revealed that the noise oversensing was most probably due to a ventricular lead issue.
Additional Manufacturer Narrative
Preliminary analysis of the returned device confirmed that electrical and mechanical characteristics were within specifications.

• 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: 9611285
• Report Number: 1000165971-2020-00231
• Device Sequence Number: 19453636
• Product Code: MRM
• UDI-Device Identifier: 08031527013916
• UDI-Public: (01)08031527013916(11)150116(17)160216
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P060027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2020

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: 02/16/2016
• Device Model Number: PARADYM RF VR 9250
• Device Catalogue Number: PARADYM RF VR 9250
• Device Lot Number: S0063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/27/2019
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 02/14/2020; 03/22/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 03/10/2020; 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1