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 Headache (1880); Hematoma (1884); Vomiting (2144)

Event Date 07/28/2021

Event Type  Injury  

Event Description

Related manufacturer reference number: 3006705815-2021-04082.It was reported the patient underwent a scs trial on (b)(6) 2021 and began experiencing a headache on the evening of (b)(6) 2021.On (b)(6) 2021 the patient was still experiencing a headache and began vomiting.The trial leads were then removed, and the patient reported the headache immediately subsided.An update was received from the physician on (b)(6) 2021 stating the patient went to the er over the weekend of (b)(6) 2021 for an unknown reason and was found to have a diffuse hematoma.The physician believed the headache was from "meninges irritation." as of (b)(6) 2021, the patient was still at the hospital and being monitored.It is unknown which lead was the problematic device therefore both are being reported.

Manufacturer Narrative

A trial patient experiencing headaches was reported to abbott.No planned intervention at this time.The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported event 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: 12341948
• MDR Text Key: 267252321
• Report Number: 3006705815-2021-04083
• 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: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: 3086
• Device Catalogue Number: 3086
• Device Lot Number: A000112088
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS TRIAL LEAD; SCS TRIAL LEAD
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 45 YR