MAUDE Adverse Event Report: ST JUDE MEDICAL, NEUROMODULATION TUNNELING TOOL; SCS LEAD ACCESSORY

Model Number 1120

Device Problem Material Fragmentation (1261)

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

Event Date 07/14/2014

Event Type  Injury  

Event Description

It was reported that the physician may have left a small plastic piece of the tunneling tool in the pt at the permanent implant procedure (on (b)(6) 2014).The physician attempted looking for it since the implant, but was unsuccessful.The pt is reported to be doing fine.

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: TUNNELING TOOL
• Type of Device: SCS LEAD ACCESSORY
• Manufacturer (Section D): ST JUDE MEDICAL, NEUROMODULATION; plano TX
• Manufacturer Contact: palka sharma ; 6901 preston rd.; plano, TX 75024 ; 9725264823
• MDR Report Key: 4132785
• MDR Text Key: 18927786
• Report Number: 1627487-2014-21644
• 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: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2016
• Device Model Number: 1120
• Device Lot Number: 4429461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2014
• Initial Date FDA Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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
• Treatment: IMPLANT DATE:; SCS IPG: MODEL 3789,; SCS LEAD: MODEL 3268 (2),; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 50 YR