Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 3028 IPG
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 3028 IPG Back to Search Results
Model Number 3028
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 06/07/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The patient has an infection that the physician is trying to treat, but he thinks we may have to explant.
 
Event or Problem Description
Patient treated with an antibiotic (bactrim) and the infection resolved without surgery.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INSPIRE MODEL 3028 IPG
Common Device Name
INSPIRE MODEL 3028 IPG
Manufacturer (Section D)
INSPIRE MEDICAL SYSTEMS
5500 wayzata blvd.
suite 1600
golden valley MN 55416
MDR Report Key8708855
Report Number3007666314-2019-00048
Device Sequence Number2387231
Product Code MNQ
UDI-Device Identifier10855728005465
UDI-Public10855728005465
Combination Product (Y/N)Y
Initial Reporter StateKY
Initial Reporter CountryUS
PMA/510(K) Number
P130008
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/06/2019
Report Date (Section F) 01/01/2005
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
Operator of Device Health Professional
Device Model Number3028
Device Catalogue Number900-007-003
Was the Report Sent to FDA? Yes
Date Report to Manufacturer01/10/2005
Initial Date Received by Manufacturer 06/12/2019
Supplement Date Received by Manufacturer09/06/2019
Initial Report FDA Received Date06/18/2019
Supplement Report FDA Received Date09/06/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other; Required Intervention;
Date Report Sent to FDA01/01/2005
-
-