MAUDE Adverse Event Report: ST JUDE MED - NEUROMODULATION PENTA; SCS LEAD

Model Number 3228

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

Patient Problems Hematoma (1884); Neurological Deficit/Dysfunction (1982); Paraplegia (2448)

Event Date 10/21/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the pt was implanted with an scs sys and was asymptomatic following the procedure.The following day the pt went to the emergency room due to a loss of motor function in the lower extremities along with sensory impairment.Once hospitalized a hematoma was found.In turn, the doctor decided to explant the lead and leave the ipg implanted.The pt's symptoms remain present at this time.

Manufacturer Narrative

Udi (di): (b)(4).Sjm has limited information 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: PENTA
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST JUDE MED - NEUROMODULATION; plano TX
• Manufacturer Contact: drew johnson ; 6901 preston rd.; plano, TX 75024 ; 9725264667
• MDR Report Key: 4257510
• MDR Text Key: 5015129
• Report Number: 1627487-2014-05775
• 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: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2016
• Device Model Number: 3228
• Device Lot Number: 4702545
• Other Device ID Number: 05414734401913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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: 3789; IMPLANT:
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR