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

Model Number 3286

Device Problem Difficult to Advance (2920)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/14/2014

Event Type  Injury  

Event Description

Device 2 of 2.Reference mfr report: 1627487-2014-02231.The pt received two 3146 scs model leads from the same lot number.It was reported the pt's permanent procedure to implant her scs leads was extended approximately one hour.The physician experienced difficulty positioning the leads.After multiple attempts the procedure was successfully completed.

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 S8
• 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: 3764915
• MDR Text Key: 4550104
• Report Number: 1627487-2014-02232
• 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: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2015
• Device Model Number: 3286
• Device Lot Number: 4215217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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: IMPLANTED:; SCS IPG: MODEL 3688; IMPLANTED:; SCS ANCHOR: MODEL 1192 (X2); IMPLANTED:; SCS EXTENSION: MODEL 3341
• Patient Outcome(s): Other
• Patient Age: 51 YR