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

Model Number 1112

Device Problems Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/11/2015

Event Type  Injury  

Event Description

It was reported the patient underwent a permanent procedure.During the procedure, a piece of the tubing of the tunneling tool broke off while the physician was performing the tunneling.Due to the difficulty of finding the fragment, it was decided to leave the patient with the fragment inside.

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.

• 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: 4654509
• MDR Text Key: 16080326
• Report Number: 1627487-2015-07170
• 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: Other
• Type of Report: Initial
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1112
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2015
• 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: 34 YR