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	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, the patient went to emergency service and was admitted at hospital because the device was delivering inappropriate shocks due to noises in right ventricular channel.The therapies were deactivated and the patient remained admitted at the hospital.As a consequence the following remote follow-ups were checked: on (b)(6) 2018, the ¿v oversensing suspected¿ remote warning was received with respectively 23, 2 and 3 non treated events.The reports showed a drop of the ventricular sensing and some abnormal right ventricular impedance lead values.The egm¿s events showed noise in the right ventricular channel too.Finally on (b)(6) 2018, the re-intervention was performed suspecting of a lead/connection issue.The lead volta 1cr65, s/n (b)(4), was checked several times with the medtronic pacing system analyzer and it seemed that the lead was ok, since no noises were detected when moving the patient arm and the impedance and detection values were stable and correct.Both the subject device and the ventricular lead were explanted without problems.
Event or Problem Description
On (b)(6) 2018, the patient went to emergency service and was admitted at hospital because the device was delivering inappropriate shocks due to noises in right ventricular channel.The therapies were deactivated and the patient remained admitted at the hospital.As a consequence the following remote follow-ups were checked: on (b)(6) 2018, the ¿v oversensing suspected¿ remote warning was received with respectively 23, 2 and 3 non treated events.The reports showed a drop of the ventricular sensing and some abnormal right ventricular impedance lead values.The egm¿s events showed noise in the right ventricular channel too.Finally on (b)(6) 2018, the re-intervention was performed suspecting of a lead/connection issue.The lead volta 1cr65, s/n (b)(4), was checked several times with the medtronic pacing system analyzer and it seemed that the lead was ok, since no noises were detected when moving the patient arm and the impedance and detection values were stable and correct.Both the subject device and the ventricular lead were explanted without problems.
Additional Manufacturer Narrative
The preliminary analysis identified a lead issue as the most likely root-cause.
Event or Problem Description
On (b)(6) 2018, the patient went to emergency service and was admitted at hospital because the device was delivering inappropriate shocks due to noises in right ventricular channel.The therapies were deactivated and the patient remained admitted at the hospital.As a consequence the following remote follow-ups were checked: on (b)(6) 2018, the ¿v oversensing suspected¿ remote warning was received with respectively 23, 2 and 3 non treated events.The reports showed a drop of the ventricular sensing and some abnormal right ventricular impedance lead values.The egm¿s events showed noise in the right ventricular channel too.Finally on (b)(6) 2018, the re-intervention was performed suspecting of a lead/connection issue.The lead volta 1cr65, s/n (b)(4) was checked several times with the medtronic pacing system analyzer and it seemed that the lead was ok, since no noises were detected when moving the patient arm and the impedance and detection values were stable and correct.Both the subject device and the ventricular lead were explanted without problems.

• 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: 7432244
• Report Number: 1000165971-2018-00372
• Device Sequence Number: 16179896
• Product Code: MRM
• UDI-Device Identifier: 08031527013916
• UDI-Public: (01)08031527013916(11)150417(17)160517
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2018

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: Physician
• Device Expiration Date: 05/17/2016
• Device Model Number: PARADYM RF VR 9250
• Device Catalogue Number: PARADYM RF VR 9250
• Device Lot Number: S0075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Distributor Facility Aware Date: 03/22/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 04/24/2018; 06/05/2018
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 05/09/2018; 06/18/2018
• 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