MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE 88; SCS LEAD

Model Number 3288

Device Problems Device Operates Differently Than Expected (2913); Battery Problem: Low Impedance (2973)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/09/2014

Event Type  Injury  

Event Description

It was reported the patient's experiencing low impedance on 15 contacts and as a result is without stimulation.Follow-up identified surgical intervention was undertaken on (b)(6) 2014 explanting and replacing the leads.The physician electively replaced the ipg during the same procedure due to its age.Effective stimulation was achieved postoperatively.The issue is resolved.

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 88
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: melissa nkematu ; 6901 preston rd.; plano, TX 75024 ; 9723092520
• MDR Report Key: 4001573
• MDR Text Key: 4955991
• Report Number: 1627487-2014-01426
• 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: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2008
• Device Model Number: 3288
• Device Lot Number: 63646
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/18/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCS IPG: MODEL 3716; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 42 YR