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

Model Number	1001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This 3500a form, report number 3009144177-2026-00004 is an identical copy of failed 3500a form submission, report number 3009144-2025-00002 originally submitted on 29jan2025.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.
Event or Problem Description
On (b)(6) 2023 the patient was implanted with a remede system for central sleep apnea.The patient was receiving therapy and doing well with csa control noted on psg.On (b)(6) 2024 the patient had an office visit after missing multiple scheduled visits.Patient was agitated and stating the therapy was not benefiting her and that she wanted the device explanted.It was noted at that time by the husband and physician that the patient had increased cognitive impairment with possible onset of dementia with a consultation to neurology.On (b)(6) 2024 the patient had an appointment with sleep physician and patient was educated on sleep hygiene and importance of establishing a nightly routine.Patient indicated she did not want to make any changes to her routine and that she wanted the device explanted.The physician and patient discussed and device was placed in "off" mode.On (b)(6) 2025 the patient called the patient education line at zoll respicardia and indicated on an unknown date she had her ipg explanted and on (b)(6) 2024 she had a procedure to have the remede system lead explanted.The patient indicated that when the physician, dr.(b)(6), attempted to remove the lead it caused a "vein to rupture and she lost 4 units of blood and life saving measures were performed during the procedure and she was in the hospital for 15 days".The lead was not able to be explanted according to the patient.Zoll respicardia has reached out to the explanting physician for more information but has not received any further details.

• 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 dr suite 150; minnetonka MN 55343
• Manufacturer Contact: kevin bentley ; 12400 whitewater dr suite 150; minnetonka, MN 55343 ; 9525404470
• MDR Report Key: 24022488
• Report Number: 3009144177-2026-00004
• Device Sequence Number: 18821287
• Product Code: PSR
• UDI-Device Identifier: 00857688007001
• UDI-Public: (01)00857688007001
• 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
• 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): 01/09/2026

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: 07/01/2024
• Device Model Number: 1001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White