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

Model Number PARADYM RF DR 9550

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)

Patient Problem No Information (3190)

Event Date 06/11/2020

Event Type  Injury  

Event 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 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.

Manufacturer Narrative

Please refer to the attached analysis report.

• Brand Name: PARADYM RF
• Type of Device: 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
• MDR Text Key: 199516757
• Report Number: 1000165971-2020-00514
• Device Sequence Number: 1
• Product Code: MRM
• UDI-Device Identifier: 08031527012254
• UDI-Public: (01)08031527012254(11)151006(17)161106
• Combination Product (y/n): N
• PMA/PMN Number: P060027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 08/19/2020
• Supplement Dates FDA Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention