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

Model Number 3228

Device Problem Difficult to Advance (2920)

Patient Problems Hematoma (1884); Neurological Deficit/Dysfunction (1982); Numbness (2415)

Event Date 11/05/2014

Event Type  Injury  

Event Description

It was reported the physician experienced difficulty with lead placement during the permanent implant procedure due to epidural scarring.Subsequently, the patient experienced bilateral leg numbness and difficulty moving her legs hours after post-operative programming.An additional surgery was undertaken on (b)(6) 2014 at which time an epidural hematoma was observed.A laminectomy was performed to relieve pressure, the hematoma evacuated, and a jackson-pratt drain placed.The lead was explanted and replaced with a different model which resolved the issue.

Event Description

Follow-up identified the patient's showing gait improvement.

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.

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: 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; 6901 preston rd; plano TX 75024
• Manufacturer Contact: st. jude medical neuromodulation division; 6901 preston road; plano, texas 75024
• MDR Report Key: 4292142
• MDR Text Key: 5270570
• Report Number: 1627487-2014-01773
• 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: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 03/28/2016
• Device Model Number: 3228
• Device Lot Number: 4511263
• Other Device ID Number: 05141734401913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2014
• 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 3789, SCS IPG, IMPLANT DATE:
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR