MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE TRIPOLE 16 LEAD, 60 CM; SCS LEAD

Model Number 3219

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

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

Event Date 04/01/2016

Event Type  Injury  

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.(b)(4).

Event Description

It was reported the patient experienced an epidural hematoma at the lead site along with motor and sensory loss in lower extremities.Reportedly, the patient had a permanent trial on (b)(6) 2016 wherein a competitor's dural separator was used during the procedure.Further, the patient was presented at the er on (b)(6) 2016 with motor and sensory loss in both legs.Surgical intervention was taken on (b)(6) 2016 where the lead was explanted and the hematoma was evacuated.As of (b)(6) 2016, the patient's right leg motor and sensory function had returned.As of (b)(6) 2016 patient still cannot move the left leg, but is regaining some sensation.Reportedly, the patient is in rehabilitation as of (b)(6) 2016.

Event Description

Further follow up identified the left leg weakness continues to improve.The patient is able to use a walker and wheelchair to get around.

Event Description

Further follow up received identified the patient is home and doing physical therapy.Also, the patient's left leg mobility is improving.

• Brand Name: LAMITRODE TRIPOLE 16 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
• MDR Report Key: 5611567
• MDR Text Key: 43768642
• Report Number: 1627487-2016-02092
• 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,Followup
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 3219
• Device Lot Number: 5124563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 48 YR