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

Model Number 3244

Device Problems Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problems Abdominal Pain (1685); Inadequate Pain Relief (2388)

Event Date 01/21/2014

Event Type  Injury  

Event Description

Device 4 of 5.Reference mfr report#: 1627487-2014-23108, 23109, 23110, 23117.It was reported the patient underwent a procedure for a permanent scs system on (b)(6) 2014.Following the procedure, the patient experienced intense abdominal pain.The sjm representative confirmed the patient had effective coverage and all impedance readings were normal.The patient's stimulation was turned off; however, this had no effect on his abdominal pain.The patient has a history of kidney stone.The patient was admitted to the hospital.Follow-up information revealed the patient's abdominal pain had decreased.The patient only felt pain on the right side of his abdomen.It was also reported the patient's stimulation could not be turned on due to invalid impedance readings.The patient only had coverage in his left leg.Reprogramming was unable to resolve the issue.X-rays were taken; however, the results are unknown.The patient underwent surgical intervention on (b)(6) 2014 and the model 3244 lead was connected to the model 3341 extension.The patient reported effective stimulation coverage postoperative.Further follow-up indicated the patient is continuing to experience right sided abdominal pain.

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
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: jennifer shepard ; 6901 preston rd.; plano, TX 75024 ; 9725264657
• MDR Report Key: 3683275
• MDR Text Key: 4260974
• Report Number: 1627487-2014-23111
• 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: 01/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2015
• Device Model Number: 3244
• Device Lot Number: 4372893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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
• Patient Outcome(s): Other
• Patient Age: 70 YR