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

Model Number 3286

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Shaking/Tremors (2515)

Event Date 02/26/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report: 1627487-2014-10081.It was reported the patient (b)(6) was unable to feel stimulation while in the recovery room.Stimulation amplitude was increased in an effort to resolve the issue; however, this resulted in the patient experiencing tremors in her legs.Diagnostic testing revealed impedance values within normal range.The physician elected to proceed with surgical intervention.Intraoperative testing yielded the same results.The physician then decided to explant and replace the lead; however, due to the patient's scar tissue in the epidural space, introducing a new lead was not possible.The hospital reported the procedure began as an exploration of the scs system (reason not provided).It was noted that the ipg was implanted in the existing pocket and remains in situ.

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: karin bechler ; 6901 preston rd.; plano, TX 75024 ; 9723092511
• MDR Report Key: 3720925
• MDR Text Key: 4277408
• Report Number: 1627487-2014-10080
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2012
• Device Model Number: 3286
• Device Lot Number: 3185613
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/14/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2010
• 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: SCS IPG: MODEL UNK
• Patient Outcome(s): Other