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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 3028 IPG
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INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 3028 IPG Back to Search Results
Model Number 3028
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code Twiddlers Syndrome (2114)
Date of Event 05/31/2019
Type of Reportable Event Serious Injury
Event or Problem Description
During a revision which was initially intended to restore therapy, the surgeon discovered device migration.The ipg was upside down (i.E., etching deep toward the pectoralis major) upon first opening the scar capsule.The physician determined twiddling of ipg occurred (twiddler's syndrome).No prior indication from the patient or physician of device migration.In the revision, the surgeon replaced the ipg and sense lead, resolving the issue.The ipg was attached with wide set anchor points to prevent future migration.
 
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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 Key8688365
Report Number3007666314-2019-00039
Device Sequence Number2358922
Product Code MNQ
UDI-Device Identifier10855728005465
UDI-Public10855728005465
Combination Product (Y/N)Y
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P130008
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/10/2019
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
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/31/2019
Initial Report FDA Received Date06/11/2019
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
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