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

Model Number 3086

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Vomiting (2144); Headache, Lumbar Puncture (2186)

Event Date 07/06/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided when the evaluation is completed.

Event Description

Related mfr report: 3006705815-2020-02986.It was reported a cerebrospinal fluid leak occurred during the patient's scs system trial procedure.The physician opted to proceed with the procedure, the patient was given a blood patch and the procedure was completed.The patient reported having a headache postoperative.Reportedly, the patient was admitted to the emergency room two days later for nausea, vomiting, and continued headache.The patient had a sphenopalatine ganglion block done with 50% improvement in her headache.Regardless, the scs system trial was successful and the leads were removed.

Manufacturer Narrative

The results of the investigation are inconclusive since the leads were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

Event Description

Related mfr report: 3006705815-2020-02986.

• Brand Name: OCTRODE TRIAL LEAD KIT, 60CM LENGTH
• Type of Device: SCS TRIAL 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
• MDR Report Key: 10320889
• MDR Text Key: 200249182
• Report Number: 3006705815-2020-02989
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734401555
• UDI-Public: 05414734401555
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2022
• Device Model Number: 3086
• Device Catalogue Number: 3086
• Device Lot Number: A000097326
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 3086, SCS LEAD; MODEL 3086, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 18 YR
• Patient Weight: 50