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	Low impedance (2285)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The preliminary analysis "suggest" that the reported event is due to a lead issue.
Event or Problem Description
On (b)(6) 2018, during a follow-up, noise on the ventricular channel and low right ventricular lead impedance values (below 200 ohms) were detected.A breakage of the lead (volta 1cr65) was suspected, so the patient was admitted at the hospital and a re-intervention was scheduled for (b)(6).On (b)(6) 2018, before and during the re-intervention, the impedances were measured again and the measurements were normal.The physician decided to explant the subject device, as well as the ventricular lead, given the residual longevity of the icd.
Event or Problem Description
On (b)(6) 2018, during a follow-up, noise on the ventricular channel and low right ventricular lead impedance values (below 200 ohms) were detected.A breakage of the lead (volta 1cr65) was suspected, so the patient was admitted at the hospital and a re-intervention was scheduled for (b)(6).On (b)(6) 2018, before and during the re-intervention, the impedances were measured again and the measurements were normal.The physician decided to explant the subject device, as well as the ventricular lead, given the residual longevity of the icd.
Additional Manufacturer Narrative
Please refer to the attached analysis report.

• 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: 8094962
• Report Number: 1000165971-2018-01002
• Device Sequence Number: 1850674
• Product Code: MRM
• UDI-Device Identifier: 08031527013916
• UDI-Public: (01)08031527013916(11)150515(17)160615
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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: 06/15/2016
• Device Model Number: PARADYM RF VR 9250
• Device Catalogue Number: PARADYM RF VR 9250
• Device Lot Number: S0080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/29/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 12/28/2018
• 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: Hospitalization; Required Intervention