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

Model Number 3086

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

Patient Problems Hematoma (1884); Muscle Weakness (1967); Neurological Deficit/Dysfunction (1982)

Event Date 03/03/2016

Event Type  Injury  

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.(b)(4).

Event Description

The patient had two leads implanted with the same lot number.It was reported the patient underwent a trial implant procedure on (b)(6) 2016.The patient did not have any issues immediately following the procedure, and was released from the hospital to go home after post-op programming was complete.The patient's wife called the sjm representative later on (b)(6) 2016, stating the patient is not doing well.The patient was experiencing numbness in the legs and difficult walking.The physician advised the patient to take an ambulance to a medical center.The patient was treated in the er by implanting physician and an er physician on the night of (b)(6) 2016.On (b)(6) 2016, the patient was transferred to a different hospital where his trial leads were removed.It was determined the patient had developed an epidural hematoma due to taking blood thinners.The patient stayed overnight in the hospital and started physical therapy that weekend.As of (b)(6) 2016, the patient has regained feeling and movement in both legs.

• Brand Name: OCTRODE TRIAL LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: kimberly goode ; 6901 preston road; plano, TX 75024 ; 9723098541
• MDR Report Key: 5529967
• MDR Text Key: 41304496
• Report Number: 3006705815-2016-00132
• 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: 03/03/2016

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: 09/30/2017
• Device Model Number: 3086
• Device Lot Number: 5261851
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2016
• Initial Date FDA Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2015
• 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: 80 YR