MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3186

Device Problem Device Remains Activated (1525)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 08/10/2020

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

Related manufacturer reference number: 3006705815-2020-31493, 1627487-2020-33051.It was reported the patient experienced undesired stimulation regardless if therapy was on or off following an mri procedure.As a result, surgical intervention was undertaken on (b)(6) 2020 wherein the ipg was explanted to address the issue.Additional information received indicated the patient underwent surgical intervention on (b)(6) 2020 where in the leads were explanted to further address the issue.

Manufacturer Narrative

The reported uncomfortable stimulation was not confirmed.The lead was returned complete and undamaged.It passed conductivity and stress testing on all channels.When tested with the returned ipg, impedance measurement was in the expected range.No physical or functional anomaly was observed that would contribute to the reported issue.The returned lead displayed normal device characteristics.The root cause of the reported issue could not be conclusively determined.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10748517
• MDR Text Key: 213454250
• Report Number: 1627487-2020-33052
• 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: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2018
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: 5368042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS IPG; SCS LEAD; SCS IPG; SCS LEAD
• Patient Outcome(s): Other
• Patient Weight: 86