MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION TUNNELING TOOL, 12; SCS TUNNELING TOOL

Model Number 3186

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported (italy) the doctor used a tunneling tool to get through a scar tissue during the implant procedure of a lead.However, the sheath of the tunneling tool did not go through the skin.The doctor tried to pull the sheath from the insertion end but only a portion of it came out.The doctor could not find the rest of the sheath and decided to leave it in the patient's body.The procedure was completed with another tunneling tool.

• Brand Name: TUNNELING TOOL, 12
• 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
• MDR Report Key: 6233776
• MDR Text Key: 64194863
• Report Number: 1627487-2017-00133
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3186
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2016
• 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