MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE 4; SCS LEAD

Model Number 3254

Device Problem Programming Issue (3014)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 05/09/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report: 1627487-2014-02395.It was reported that pt is not receiving effective stimulation coverage of all of his pain area.A sjm representative met with the pt.A diagnostics of the pt's scs system revealed multiple invalid lead(s) contacts.Reprogramming did not resolve the issue.X-rays taken did not show any abnormalities.Surgical intervention may be undertaken at a later to address the issue.

Manufacturer Narrative

Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: LAMITRODE 4
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: arnie ochoa ; 6901 preston rd.; plano, TX 75024 ; 9723098090
• MDR Report Key: 3890681
• MDR Text Key: 4652014
• Report Number: 1627487-2014-02394
• 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: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2011
• Device Model Number: 3254
• Device Lot Number: 2874233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2009
• 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: IMPLANTED:; SCS IPG: MODEL 3788
• Patient Outcome(s): Other
• Patient Age: 50 YR