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	Over-Sensing (1438)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2016, the subject implantable cardiac defibrillator (icd) was implanted with a volta 1cr65.On (b)(6) 2018, noise on the right ventricular channel was detected during the follow-up and in the remote follow-up, suggesting some lead issue.The physician decided the replacement of all the system taking into account the patient age and the icd residual longevity.On (b)(6) 2018, the subject icd and volta lead have been explanted and replaced.The physician is assuming that the lead was broken because the patient is practicing gymnastic with weights.The preliminary analysis suggests that the reported event is due to a lead issue.
Event or Problem Description
On (b)(6) 2016, the subject implantable cardiac defibrillator (icd) was implanted with a volta 1cr65.On (b)(6) 2018, noise on the right ventricular channel was detected during the follow-up and in the remote follow-up, suggesting some lead issue.The physician decided the replacement of all the system taking into account the patient age and the icd residual longevity.On (b)(6) 2018, the subject icd and volta lead have been explanted and replaced.The physician is assuming that the lead was broken because the patient is practicing gymnastic with weights.The preliminary analysis suggests that the reported event is due to a lead issue.
Additional Manufacturer Narrative
Based on the preliminary analysis of the returned unit, no issue is suspected on the subject icd.
Event or Problem Description
On (b)(6)2016, the subject implantable cardiac defibrillator (icd) was implanted with a volta 1cr65.On (b)(6)2018, noise on the right ventricular channel was detected during the follow-up and in the remote follow-up, suggesting some lead issue.The physician decided the replacement of all the system taking into account the patient age and the icd residual longevity.On (b)(6)2018, the subject icd and volta lead have been explanted and replaced.The physician is assuming that the lead was broken because the patient is practicing gymnastic with weights.The preliminary analysis suggests that the reported event is due to a lead issue.

• 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: 8199169
• Report Number: 1000165971-2018-01112
• Device Sequence Number: 19402964
• Product Code: MRM
• UDI-Device Identifier: 08031527013916
• UDI-Public: (01)08031527013916(11)150504(17)160604
• 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: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2019

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: 06/04/2016
• Device Model Number: PARADYM RF VR 9250
• Device Catalogue Number: PARADYM RF VR 9250
• Device Lot Number: S0077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/04/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 01/10/2019; 02/15/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 01/25/2019; 02/21/2019
• 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