MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 3028 IPG

Model Number 3028

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 11/02/2020

Event Type  Injury  

Event Description

Patient experienced pain when therapy was on following cardioversion.Surgeon replaced the ipg to resolve the issue on (b)(6) 2020.

• Brand Name: INSPIRE MODEL 3028 IPG
• Type of Device: INSPIRE MODEL 3028 IPG
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS; 5500 wayzata blvd.; suite 1600; golden valley MN 55416
• Manufacturer (Section G): INSPIRE MEDICAL SYSTEMS; 5500 wayzata blvd.; suite 1600; golden valley MN 55416
• Manufacturer Contact: colleen hartwell ; 5500 wayzata blvd.; suite 1600; golden valley, MN 55416 ; 7632057970
• MDR Report Key: 10880746
• MDR Text Key: 217666141
• Report Number: 3007666314-2020-00062
• Device Sequence Number: 1
• Product Code: MNQ
• UDI-Device Identifier: 10855728005656
• UDI-Public: 10855728005656
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P130008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3028
• Device Catalogue Number: 900-007-008
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention