MAUDE Adverse Event Report: INSPIRE MEDICAL SYSTEMS INC. INSPIRE MEDICAL SYSTEMS INC; TUNNELLING TOOL

Model Number MODEL 4063

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 08/03/2016

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

Surgeon nicked the patient's jugular vein during the implant surgery, specifically while tunnelling in preparation for implant of the stimulation lead.The surgeon was abel to stop the bleeding and continued with the implant of the system.The patient is doing well and is responding nicely to the therapy but the patients surgical procedure was prolonged by 2.5 hours as a result this event.

• Brand Name: INSPIRE MEDICAL SYSTEMS INC
• Type of Device: TUNNELLING TOOL
• 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; suite 200; maple grove, MN 55369 ; 7632057972
• MDR Report Key: 6059123
• MDR Text Key: 58452450
• Report Number: 3007666314-2016-00010
• Device Sequence Number: 1
• Product Code: MNQ
• UDI-Device Identifier: 00855728005017
• UDI-Public: 00855728005017
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• 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: 900-001-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization