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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 4063 STIMULATION LEAD
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INSPIRE MEDICAL SYSTEMS INSPIRE MODEL 4063 STIMULATION LEAD Back to Search Results
Model Number 4063
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Abscess (1690); Unspecified Infection (1930)
Date of Event 03/20/2019
Type of Reportable Event Serious Injury
Event or Problem Description
The patient was brought back into the or several months after implant due to an abscess at the neck incision.
 
Event or Problem Description
The infection was recurrent and the physician referred the patient to id for picc line and iv antibiotics.After treatment, the infection was resolved without further surgical intervention.
 
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Brand Name
INSPIRE MODEL 4063 STIMULATION LEAD
Common Device Name
INSPIRE MODEL 4063 STIMULATION LEAD
Manufacturer (Section D)
INSPIRE MEDICAL SYSTEMS
5500 wayzata blvd.
suite 1600
golden valley MN 55416
MDR Report Key8444515
Report Number3007666314-2019-00025
Device Sequence Number19542916
Product Code MNQ
UDI-Device Identifier10855728005397
UDI-Public10855728005397
Combination Product (Y/N)Y
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
P130008
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 07/29/2019
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 Number4063
Device Catalogue Number900-001-007
Was the Report Sent to FDA? Yes
Date Report to Manufacturer01/10/2005
Initial Date Received by Manufacturer 03/20/2019
Supplement Date Received by Manufacturer07/12/2019
Initial Report FDA Received Date03/22/2019
Supplement Report FDA Received Date07/29/2019
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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