MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION TUNNELLING TOOL

Model Number 1112

Device Problem Device Handling Problem (3265)

Patient Problem Discomfort (2330)

Event Date 12/06/2013

Event Type  Injury  

Event Description

It was reported the patient noticed a bump under her skin.X-rays were taken and it was determined the tunnelling tool was left inside the patient and was protruding.There is no further intervention planned for this issue.

Manufacturer Narrative

Sjm 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.Sjm defers to the patient's physician regarding medical history.

• Brand Name: TUNNELLING TOOL
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: ahmad johnson ; 6901 preston rd.; plano, TX 75024 ; 9725264667
• MDR Report Key: 3674186
• MDR Text Key: 4302026
• Report Number: 1627487-2014-05016
• Device Sequence Number: 1
• Product Code: GZB
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/06/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2013
• 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): Other
• Patient Age: 50 YR