MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE; IMPLANTABLE PULSE GENERATOR

Model Number 3024

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/09/2019

Event Type  Injury  

Event Description

Physician suspects patient may be allergic to a material of the implanted system.

Manufacturer Narrative

Patient issue not related to inspire system.

Event Description

The patient's implanting physician office stated there were zero positive allergic reactions when the patient was tested, based on inspire's material list.Patient's issues not related to the inspire system.

• Brand Name: INSPIRE
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS; 5500 wayzata blvd.; suite 1600; golden valley MN 55416
• MDR Report Key: 8248682
• MDR Text Key: 133085469
• Report Number: 3007666314-2019-00002
• Device Sequence Number: 1
• Product Code: MNQ
• UDI-Device Identifier: 00855728005024
• UDI-Public: 00855728005024
• Combination Product (y/n): Y
• PMA/PMN Number: P130008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3024
• Device Catalogue Number: 900-003-015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other