MAUDE Adverse Event Report: ZOLL RESPICARDIA INC. REMEDE SYSTEM; IMPLANTED PHRENIC NERVE STIMULATOR FOR CENTRAL SLEEP APNEA

Model Number	1100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On an unknown date in 2024, an (b)(6) y.O.Male status post zoll respicardia remede central sleep apnea device implanted in (b)(6) 2023 presented with complaints of right arm swelling.An ultrasound was done on an unknown date in 2024 that showed the following: right upper extremity deep veins: internal jugular: patent.Subclavian: nearly occlusive thrombus.Axillary: occlusive thrombus.Brachial: patent and compressible.Right upper extremity superficial veins.Basilic: patent and compressible.Cephalic: patent and compressible.On (b)(6) 2024 the patient was evaluated by the remede implanting physician who indicated the patient stated the right arm swelling had improved after initiation of eliquis 5 mg twice a day.On (b)(6) 2024 the patient remede system was successfully explanted per patient preference.
Additional Manufacturer Narrative
This 3500a form, is an identical copy of failed 3500a form submission, report number 3009144-2024-00009 originally submitted on 27nov2024.The original 3500a form failed at ack3 due to the following error: only one pma/510(k) is allowed per report.This error has been corrected.A capa was opened to prevent reoccurrence of the failed submission.

• Brand Name: REMEDE SYSTEM
• Common Device Name: IMPLANTED PHRENIC NERVE STIMULATOR FOR CENTRAL SLEEP APNEA
• Manufacturer (Section D): ZOLL RESPICARDIA INC.; 12400 whitewater dr; suite 150; minnetonka MN 55343
• Manufacturer (Section G): ZOLL RESPICARDIA, INC.; 12400 whitewater drive; suite 150; minnetonka MN 55343
• Manufacturer Contact: kevin bentley ; 12400 whitewater drive; suite 150; minnetonka, MN 55343 ; 6122865999
• MDR Report Key: 24096039
• Report Number: 3009144177-2026-00009
• Device Sequence Number: 10468785
• Product Code: PSR
• UDI-Device Identifier: 00857688007391
• UDI-Public: (01)00857688007391
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P160039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

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 Expiration Date: 05/09/2025
• Device Model Number: 1100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White