MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE TRIPOLE 16; SCS LEAD

Model Number 3219

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); High Blood Pressure/ Hypertension (1908); Pain (1994)

Event Date 06/02/2014

Event Type  Injury  

Event Description

It was reported the patient underwent a scs system implant procedure.Post operatively the patient complained of abdominal pain and weakness in both legs.The patient had developed a hematoma near the lead site incision and also had elevated blood pressure.The physician explanted the scs system and the patient was hospitalized.Follow up revealed the patient's symptoms are improving.

Manufacturer Narrative

Results & conclusions: the complaint of "neurological deficit disorder" could not confirm through products testing alone.As received, the lead was cut but complete.The lead was returned cut as a result of the explant procedure.It had some discoloration on paddle and one of the terminal end lead segment.All lead segments were inspected under the microscope and no broken wires were observed.The returned ipg was functionally tested and passed all testing.Visual and functional analysis of the returned products did not reveal any anomalies that would contribute to the reported complaint.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 TRIPOLE 16
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: connie timmons ; 6901 preston rd.; plano, TX 75024 ; 9723098054
• MDR Report Key: 4001593
• MDR Text Key: 21729171
• Report Number: 1627487-2014-12435
• 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: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Model Number: 3219
• Device Lot Number: 4287114
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/09/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2014
• Initial Date FDA Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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: SCS IPG: MODEL 3788; IMPLANT DATE:
• Patient Outcome(s): Hospitalization
• Patient Age: 84 YR