MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S-8 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3286

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 12/19/2014

Event Type  Injury  

Event Description

It was reported, the patient underwent surgical intervention for a lead replacement on (b)(6) 2014 (reference mfr.Report#: 1627487-2014-23411).However, during the procedure, the physician attempted to place a paddle lead, but the epidural space would not allow the placement of the product.As a result, the physician abandoned the procedure.

Manufacturer Narrative

(b0(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: LAMITRODE S-8 LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano, texas
• Manufacturer Contact: st. jude medical - neuromodulation; 6901 preston rd; plano 75024
• MDR Report Key: 4423784
• MDR Text Key: 5166319
• Report Number: 1627487-2015-23029
• 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: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2015
• Device Model Number: 3286
• Device Lot Number: 4215207
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2013
• 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: MODEL 3789, SCS IPG, IMPLANT DATE; MODEL 3186 (2), SCS LEAD, IMPLANT DATE; MODEL 1192 (2), SCS ANCHOR, IMPLANT DATE
• Patient Outcome(s): Other
• Patient Age: 60 YR