MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S8; SCS LEAD

Model Number 3286

Device Problem Failure to Advance (2524)

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

Event Date 07/11/2014

Event Type  Injury  

Event Description

Device 4 of 5.Reference mfr.Reports#: 1627487-2014-05559, 1627487-2014-05560, 1627487-2014-05561, 1627487-2014-05563.On (b)(6) 2014, the patient underwent a permanent implant procedure to receive two scs systems.The scs system for the patient's cervical area was implanted successfully.Several issues occurred upon attempting to implant the scs system for the lumbar area.Stimulation in an unintended area occurred after a 3286 lead and two, 3166 leads were placed.This was due to the leads not remaining stationary.In turn, the doctor removed the leads and attempted to place another 3286 lead to no avail.The 3286 lead was dropped after several attempts to implant.Next, the doctor placed both 3166 leads that were removed prior successfully and good coverage was present.The doctor attempted to place a 3186 lead but was also unsuccessful.As a result, the doctor chose to remove both 3166 leads and the 3186 lead.The procedure was abandoned after 6 hours.

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: LAMITRODE S8
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: drew johnson ; 6901 preston rd.; plano, TX 75024 ; 9725264667
• MDR Report Key: 4008953
• MDR Text Key: 4778287
• Report Number: 1627487-2014-05562
• 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: 07/11/2014

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: 02/01/2016
• Device Model Number: 3286
• Device Lot Number: 4469159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2014
• Initial Date FDA Received: 08/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 79 YR