MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PENTA 3MM LEAD, 60 CM; SCS LEAD

Model Number 3228

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

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

Event Date 12/09/2014

Event Type  Injury  

Event Description

Follow up information identified the patient has been discharged from the rehabilitation facility.The patient will continue with physical therapy at home until motor function has been restored.

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.

Event Description

It was reported the patient is experiencing an inability to move her legs and was transported to the er.Follow up information identified the patient underwent surgical intervention to remove the entire scs system.The patient has improved and has some motor function.The patient continues to be monitored.

Manufacturer Narrative

(b)(4).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: PENTA 3MM LEAD, 60 CM
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; st. jude medical-neuromodulation division; 6901 preston road; plano TX 75024 750
• MDR Report Key: 4366819
• MDR Text Key: 5504166
• Report Number: 1627487-2014-22051
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/21/2015

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: 09/28/2016
• Device Model Number: 3228
• Device Lot Number: 4871073
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2015
• Initial Date FDA Received: 12/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2014
• 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: MODEL 3788, SCS IPG
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR