MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE TRIAL LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3086

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

Patient Problems Abscess (1690); Fall (1848); Bone Fracture(s) (1870); Neurological Deficit/Dysfunction (1982)

Event Date 03/04/2015

Event Type  Injury  

Event Description

The patient was implanted with two trial leads having the same lot number.It was reported the patient had a successful scs trail implant on (b)(6) 2015, with the trial leads pulled on (b)(6) 2015.Reportedly, the patient suffered a fall and fractured his lower leg on (b)(6) 2015.Additionally, the patient experienced fever, nausea, vomiting and weakness 3-4 days after the lead pull on (b)(6) 2015 after the leads were pulled.Subsequently, the patient presented to the er on (b)(6) 2015 and was hospitalized.Surgical intervention was undertaken on (b)(6) 2015 for treatment of an epidural abscess.The patient was treated with iv antibiotics.Follow-up identified the abscess was removed during surgery and the patient is unable to walk or bear weight on his legs.Physical rehabilitation will be the next course of action.The physician noted the weakness/paralysis was due to the symptoms being unreported for 4-5 days as well as pre-existing comorbidities.The patient's prognosis is undetermined by the physician at this time.

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: OCTRODE TRIAL LEAD KIT, 60CM LENGTH
• 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: 4652511
• MDR Text Key: 5597366
• Report Number: 1627487-2015-08200
• 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
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2016
• Device Model Number: 3086
• Device Lot Number: 4866211
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2014
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR