MAUDE Adverse Event Report: ST. JUDE MEDICAL NEUROMODULATION DIVISION OCTRODE TRIAL LEAD KIT, 60CM LENGTH

Model Number 3086

Device Problem Difficult to Advance (2920)

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

Event Date 03/10/2015

Event Type  Injury  

Event Description

It was reported the patient underwent a trial procedure and during the procedure the physician was unable to advance the lead and the procedure was abandoned.

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: OCTRODE TRIAL LEAD KIT, 60CM LENGTH
• Type of Device: TRIAL LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL NEUROMODULATION DIVISION; 6901 preston road; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL NEUROMODULATION DIVISION; 6901 preston road; plano TX 75024
• MDR Report Key: 4649268
• MDR Text Key: 20786718
• Report Number: 1627487-2015-26132
• 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: 03/10/2015

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: 10/28/2016
• Device Model Number: 3086
• Device Catalogue Number: 3086
• Device Lot Number: 4819952
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2015
• Initial Date FDA Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 72 YR