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 Codes	High impedance (1291); Delayed Charge Time (2586)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The defibrillation system was implanted on (b)(6) 2016.Reportedly, an alert stating that the ventricular lead impedance was saturated at 3000 ohms on (b)(6) 2020 was transmitted by remote monitoring on (b)(6) 2020.As a result, the patient was admitted to the hospital for a follow-up on (b)(6) 2020.The ventricular lead impedance was measured at 2700 ohms, but the rv coil continuity trend was within normal range.The battery voltage was measured at 2.95 v on (b)(6) 2020, and the last charge time recorded in (b)(6) 2020 was 14.5 s.Preliminary analysis revealed that the reported behavior most probably resulted from a gradual ventricular lead issue or a gradual physiological phenomenon occurring at the implant site.Following the recommendations sent on (b)(6) 2020, the associated ventricular lead was replaced on (b)(6) 2020.However, possible fibrosis around the lead tip and the coil prevented its extraction.As a result, the ventricular lead was abandoned in patient's body.It was decided to explant the icd during the same medical procedure, considering its remaining residual longevity.
Event or Problem Description
The defibrillation system was implanted on (b)(6) 2016.Reportedly, an alert stating that the ventricular lead impedance was saturated at 3000 ohms on (b)(6) 2020 was transmitted by remote monitoring on (b)(6) 2020.As a result, the patient was admitted to the hospital for a follow-up on (b)(6) 2020.The ventricular lead impedance was measured at 2700 ohms, but the rv coil continuity trend was within normal range.The battery voltage was measured at 2.95 v on (b)(6) 2020, and the last charge time recorded in (b)(6) 2020 was 14.5 s.Preliminary analysis revealed that the reported behavior most probably resulted from a gradual ventricular lead issue or a gradual physiological phenomenon occurring at the implant site.Following the recommendations sent on 30 november 2020, the associated ventricular lead was replaced on (b)(6) 2020.However, possible fibrosis around the lead tip and the coil prevented its extraction.As a result, the ventricular lead was abandoned in patient's body.It was decided to explant the icd during the same medical procedure, considering its remaining residual longevity.
Additional Manufacturer Narrative
Please refer to analysis report.

• Brand Name: PARADYM RF
• Common Device Name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; via crescentino s.n.; .; saluggia (vc) 13040 ; IT 13040
• MDR Report Key: 11026264
• Report Number: 1000165971-2020-00810
• Device Sequence Number: 629121
• Product Code: MRM
• UDI-Device Identifier: 08031527013916
• UDI-Public: (01)08031527013916(11)150430(17)160530
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2021

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: 05/30/2016
• 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: 01/06/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/26/2020
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 02/22/2021
• 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