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 Fever (1858); Burning Sensation (2146); Discharge (2225)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Device 1 of 4.Related manufacturer reference number: 3006705815-2020-31226.Related manufacturer reference number: 1627487-2020-31061.Related manufacturer reference number: 1627487-2020-31062.It was reported the patient experienced burning sensation and drainage at the lead incision site, along with a low grade fever.A ct scan was normal.To address the issue, the physician opted to explant the patient¿s system.

Event Description

Additional information was received and confirmed the physician treated this issue with oral antibiotics.The issue is now resolved.

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: 10491914
• MDR Text Key: 205644360
• Report Number: 3006705815-2020-31225
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2021
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000091183
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 1192 (X2); MODEL 3186
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 129