MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION TUNNELING TOOL, 20; SCS TUNNELING TOOL

Model Number 1120

Device Problem Use of Device Problem (1670)

Patient Problem Respiratory Distress (2045)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Manufacturer defers to the patient's physician regarding medical history.

Event Description

It was reported that during the lead revision procedure the patients breathing pattern changed.There was blood founded in the respiratory tube.Physician believed he reached the patient's lungs with the tunneling tool.No abnormalities were found through diagnostic tests.In turn, the patient stayed the night in the icu for observation.Reportedly, the issue was resolved and effective therapy was restored post operatively.

• Brand Name: TUNNELING TOOL, 20
• Type of Device: SCS TUNNELING TOOL
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: falon whitfield ; 9725268233
• MDR Report Key: 7612185
• MDR Text Key: 111425878
• Report Number: 1627487-2018-05647
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734400176
• UDI-Public: 05414734400176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2020
• Device Model Number: 1120
• Device Lot Number: 6317443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2018
• 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