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

Model Number 3186

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

Patient Problems Headache (1880); Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 07/30/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer reference number 3006705815-2021-03946, 1627487-2021-16266, 1627487-2021-16267.It was reported that the patient was experiencing headaches along with green discharge at the lead site.As a result, surgical intervention is pending to address the issue.

Event Description

Additional information indicated a surgical intervention occurred wherein the system was explanted to address the issue.

Manufacturer Narrative

An event of infection was reported to abbott.It was conveyed that the infection originates at the lead(s) and anchor site(s).The entire system was explanted; however, no explanted products were returned for analysis.As a result, a device history record was performed to review and confirm the sterility of the lead(s) and anchor(s).Based on the documents reviewed, the source of the infection remains unknown.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: PERCUTANEOUS 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: 12311034
• MDR Text Key: 266162776
• Report Number: 3006705815-2021-03947
• 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,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2022
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000101675
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANCHOR X2.; PERCUTANEOUS LEAD.; ANCHOR X2.; PERCUTANEOUS LEAD.
• Patient Outcome(s): Other