MAUDE Adverse Event Report: ZOLL RESPICARDIA, INC. REMEDE SYSTEM; IMPLANTED PHRENIC NERVE STIMULATOR FOR CSA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 12/26/2021

Event Type  Injury  

Event Description

Patient reported swelling and pain in the right arm.Ultrasound confirmed a dvt involving the right internal jugular vein, subclavian vein, axillary vein, and brachial vein treated with anticoagulant.Issue resolved.

Manufacturer Narrative

On (b)(6) 2021 the patient underwent a successful remede system implant for central sleep apnea consisting of an implantable pulse generator, a respicardia 4065 stimulation lead, and an abbott 1258t-86 sensing lead.On (b)(6) 2021, the subject reported they had swelling and pain in the right arm treated with tylenol and tramadol with no resolution of pain.On (b)(6) 2021 an ultrasound was reported that demonstrated a dvt involving the right internal jugular vein, subclavian vein, axillary vein, and brachial vein.There was a note of superficial thrombus in the right basilic vein.The patient was started on xarelto 15 mg twice a day for 21 days, followed by 20 mg a day, and norco for pain control.On (b)(6) 2022, the patient was seen in the emergency room for continued pain, while better remained poorly controlled.Pain medication was changed to oxycontin 15 mg twice daily and oxycodone ir for breakthrough pain.It was noted that the swelling in the right neck and right upper extremity had significantly decreased.On (b)(6) 2022 the patient changed to warfarin for cost reasons.In (b)(6) 2022, the subject was evaluated in a medical office and found to be doing great.

• Brand Name: REMEDE SYSTEM
• Type of Device: IMPLANTED PHRENIC NERVE STIMULATOR FOR CSA
• Manufacturer (Section D): ZOLL RESPICARDIA, INC.; 12400 whitewater drive; 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: 15459110
• MDR Text Key: 300295855
• Report Number: 3009144177-2022-00002
• Device Sequence Number: 1
• Product Code: PSR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/08/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female