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

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/15/2022

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2021 the patient underwent a successful remede system implant for central sleep apnea consisting of an implantable pulse generator and a respicardia 4065 stimulation lead.In (b)(6) 2022 patient underwent a permanent pacemaker implant for unknown reason.In mid-(b)(6) 2022 the patient was admitted to a local hospital after suffering swelling and pain in the right arm.During that admission, the patient was found to have a right upper extremity dvt and underwent treatment (type of treatment is unknown) to resolve the dvt.Patient was discharged on (b)(6) 2022 with a follow up visit in the vascular clinic (b)(6) 2022.Patient has recovered with no permanent injury.

Event Description

Patient called zoll to report dvt in right upper arm after intervention and resolution.Patient ws was implanted with the remede system at the university of (b)(6) 2021 and did well per his report with therapy.Patient also has a pacemaker.

• Type of Device: IMPLANTED PHRENIC NERVE STIMULATOR FOR CENTRAL SLEEP APNEA
• 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: 15459068
• MDR Text Key: 300297232
• Report Number: 3009144177-2022-00001
• Device Sequence Number: 1
• Product Code: PSR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 160039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2022

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
• Initial Date Manufacturer Received: 03/22/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male