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 Cerebrospinal Fluid Leakage (1772); Headache, Lumbar Puncture (2186)

Event Date 03/15/2017

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.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

Device 2 of 2.Reference mfr report: 1627487-2017-01865.It was reported the patient suffered a csf leak during the trial implant procedure on (b)(6) 2017.The physician placed the first trial lead on the left side, without issue.While inserting the epidural needle to access the right side for the second lead, the patient suffered a csf leak.The second lead was not implanted.The physician decided to complete the procedure with the one lead and was able to capture effective coverage.The next day the patient was experiencing a severe headache.On (b)(6) 2017, the physician performed a blood patch and pulled the one trial lead implanted.Follow up information identified the patient is doing better and the headache is resolved.The device information is unavailable for the epidural needle.

• 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: 6478105
• MDR Text Key: 72331468
• Report Number: 1627487-2017-01866
• 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: 04/10/2017

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: 01/27/2019
• Device Model Number: 3086
• Device Lot Number: 5825164
• Other Device ID Number: 05414734401555
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2017
• Initial Date FDA Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2017
• 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: 61 YR