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

Model Number 3186

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880); Dizziness (2194)

Event Date 07/08/2021

Event Type  Injury  

Event Description

Related manufacturer reference number: 3006705815-2021-03877.It was reported that the patient suffered a cerebrospinal fluid (csf) lead from an explant procedure on (b)(6) 2021 (reference manufacturer report number 3006705815-2021-03223 and 3006705815-2021-03224).Patient experienced headache and dizziness.As such, the patient was given a binder and pressure pack.Patient was hospitalized to address the issue.Reportedly, patient has been discharged from the hospital and the headache/dizziness are better.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• Brand Name: OCTRODE 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
• MDR Report Key: 12297916
• MDR Text Key: 265799095
• Report Number: 3006705815-2021-03876
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2022
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000099645
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS LEAD, MODEL 3186
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 79