MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number	PARADYM RF DR 9550
Medical Device Problem Codes	Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly, the patient was admitted to the hospital after having received several inappropriate shocks both at home and at the hospital.A magnet was applied on the icd until a company representative could interrogate the icd.Device interrogation revealed that ventricular coil continuity measurements were below 200 ohms.Since (b)(6) 2020, non-physiological signals with fast rhythm were observed on the ventricular channel, leading to the delivery of inappropriate therapies since (b)(6) 2020.Though the right lead impedance curve was relatively stable, punctual variations of more than 200 ohms were noted since (b)(6) 2020.Consequently, it was decided to turn off the therapies.A revision of the defibrillation system and its replacement were performed on (b)(6) 2020, as the consecutive shock deliveries could have induced a decrease of the battery longevity.Preliminary analysis revealed that the inappropriate shocks delivered on (b)(6) 2020 most probably resulted from a ventricular lead issue.
Event or Problem Description
Reportedly, the patient was admitted to the hospital after having received several inappropriate shocks both at home and at the hospital.A magnet was applied on the icd until a company representative could interrogate the icd.Device interrogation revealed that ventricular coil continuity measurements were below 200 ohms.Since 1 (b)(6)2020 , non-physiological signals with fast rhythm were observed on the ventricular channel, leading to the delivery of inappropriate therapies since (b)(6)2020.Though the right lead impedance curve was relatively stable, punctual variations of more than 200 ohms were noted since (b)(6)2020.Consequently, it was decided to turn off the therapies.A revision of the defibrillation system and its replacement were performed on (b)(6)2020 , as the consecutive shock deliveries could have induced a decrease of the battery longevity.Preliminary analysis revealed that the inappropriate shocks delivered on (b)(6)2020 most probably resulted from a ventricular lead issue.
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: 10295421
• Report Number: 1000165971-2020-00514
• Device Sequence Number: 2603431
• Product Code: MRM
• UDI-Device Identifier: 08031527012254
• UDI-Public: (01)08031527012254(11)151006(17)161106
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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: 11/06/2016
• Device Model Number: PARADYM RF DR 9550
• Device Catalogue Number: PARADYM RF DR 9550
• Device Lot Number: S0117
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/25/2020
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 08/28/2020
• 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