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 Problem Burning Sensation (2146)

Event Date 07/30/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated during processing of this incident, attempts were made to obtain complete patient information.

Event Description

Related manufacturer reference number: 3006705815-2021-04247.Related manufacturer reference number: 3006705815-2021-04249.It was reported that the patient experienced pain/burning sensation at the ipg site.Reportedly, the burning sensation radiates from lower back to legs.The sensation persisted with stimulation on.The ipg site was not warm to touch.Impedance check revealed low impedance on 2 contacts that were not used in the programs.In turn, surgical intervention took place on (b)(6) 2021 wherein the entire system was explanted to address the issue.

Event Description

Reportedly, the issue persisted with stimulation on and off.

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: 12385380
• MDR Text Key: 268719550
• Report Number: 3006705815-2021-04248
• 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
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2022
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000103448
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS IPG, MODEL 3660; SCS IPG, MODEL 3660
• Patient Outcome(s): Other
• Patient Age: 51 YR