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 Problem Headache (1880)

Event Date 05/26/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer reference number 3006705815-2021-02842.It was reported a cerebrospinal fluid (csf) leak occurred during a trial procedure on (b)(6) 2021.The patient reported a headache afterwards.In turn, trial leads were pulled out.As a result, medical intervention may take place at a later date to address the issue.

Manufacturer Narrative

A cerebrospinal fluid leak (csf) during implantation was reported to abbott.Multiple attempts to reach the patient have been unsuccessful with no response from the patient.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 11973745
• MDR Text Key: 255335667
• Report Number: 3006705815-2021-02843
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 08/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2023
• Device Model Number: 3086
• Device Catalogue Number: 3086
• Device Lot Number: A000105584
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS TRIAL LEAD; SCS TRIAL LEAD
• Patient Outcome(s): Other
• Patient Weight: 82