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

Model Number 3186

Device Problem Low impedance (2285)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2023

Event Type  Injury  

Event Description

It was reported that the patient's ipg is unable to enter mri mode due to low impedances.Troubleshooting was unable to resolve the issue.As a result, surgical intervention may be undertaken at a later date to address the issue.It is unknown which lead has the low impedances.

Manufacturer Narrative

Date of event is estimated.The allegation is against 1 of 2 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: scs octrode lead, model: 3186, udi: (b)(4), serial: n/a, batch: 3126663.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Additional information indicates that surgical intervention was undertaken on (b)(6) 2024 wherein the ipg was electively explanted and replaced to address the issue.No intervention occurred on the leads.Effective therapy was restored post-op.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident 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
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 17716461
• MDR Text Key: 323036141
• Report Number: 1627487-2023-04286
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734406130
• UDI-Public: 05414734406130
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2012
• Device Model Number: 3186
• Device Lot Number: 3126663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 11/01/2023; 01/30/2024; 04/06/2024
• Supplement Dates FDA Received: 11/09/2023; 02/22/2024; 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2010
• 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: SCS ANCHOR (2).; SCS IPG.; SCS LEAD.
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 113 KG