MAUDE Adverse Event Report: ADVANCED NEUROMODULATION SYSTEMS PENTA; SCS LEAD

Model Number 3228

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913); Difficult to Advance (2920)

Patient Problems Therapeutic Effects, Unexpected (2099); Inadequate Pain Relief (2388)

Event Date 02/21/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient rec'd an scs system.During the procedure, the doctor experienced difficulty implanting the lead due to the patient's anatomy.Post-op, effective stimulation could not be achieved due to the patient receiving stimulation in unintended areas.As a result, the patient's lead was repositioned the following day.

Manufacturer Narrative

Sjm has limited info 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: PENTA
• Type of Device: SCS LEAD
• Manufacturer (Section D): ADVANCED NEUROMODULATION SYSTEMS; plano TX
• Manufacturer Contact: ahmad johnson ; 6901 preston rd.; plano, TX 75024 ; 9725264667
• MDR Report Key: 3692754
• MDR Text Key: 19586663
• Report Number: 1627487-2014-05188
• 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: 02/21/2014

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: 11/01/2015
• Device Model Number: 3228
• Device Lot Number: 4358173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2014
• Initial Date FDA Received: 03/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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): Other
• Patient Age: 60 YR