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 Fever (1858); Post Operative Wound Infection (2446)

Event Date 09/03/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The device history record was reviewed to ensure proper packaging and sterility.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer reference number 3006705815-2021-04517.Related manufacturer reference number 1627487-2021-16965.Related manufacturer reference number 1627487-2021-16966.It was reported that patient experienced infection at the lead site.Reportedly, patient was treated with antibiotics and underwent surgical intervention wherein the entire system was explanted to address the issue.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 12474526
• MDR Text Key: 271480233
• Report Number: 3006705815-2021-04516
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2023
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000109658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PERCUTANEOUS LEAD; SWIFT-LOCK ANCHORS X2
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 91