MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC INSPIRE MODEL 4063 STIMULATION LEAD; NEUROSTIMULATION LEAD

Model Number MODEL 4063

Device Problem Insufficient Information (3190)

Patient Problem Post Operative Wound Infection (2446)

Event Date 07/06/2018

Event Type  Injury  

Event Description

Patient went to er with drainage from their stimulation lead's neck incision.He has been asked to come back in to the clinic for further evaluation.

Event Description

Follow up report: patient went to the er to address drainage from their stimulation lead neck incision.The physician informed us that this issue was just drainage which has resolved and there have been no further issues since.

• Brand Name: INSPIRE MODEL 4063 STIMULATION LEAD
• Type of Device: NEUROSTIMULATION LEAD
• Manufacturer (Section D): INSPIRE MEDICAL SYSTEMS INC; 9700 63rd ave n; suite 200; maple grove MN 55369
• Manufacturer (Section G): INSPIRE MEDICAL SYSTEMS INC; 9700 63rd ave n; suite 200; maple grove MN 55369
• Manufacturer Contact: joel aaberg ; 9700 63rd ave n; suite 200; maple grove, MN 55369 ; 7632057970
• MDR Report Key: 7675465
• MDR Text Key: 113591890
• Report Number: 3007666314-2018-00017
• Device Sequence Number: 1
• Product Code: MNQ
• UDI-Device Identifier: 10855728005397
• UDI-Public: 10855728005397
• Combination Product (y/n): N
• 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,Followup
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MODEL 4063
• Device Catalogue Number: 900-001-008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention