MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD KIT, 90CM LENGTH; PERCUTANEOUS LEAD

Model Number 3189

Device Problems Therapeutic or Diagnostic Output Failure (3023); Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/09/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer reference number: 1627487-2021-16549.It was reported the patient experienced ineffective therapy.In turn, surgical intervention was undertaken wherein the entire system was explanted and replaced to address the issue.

Event Description

Related manufacturer reference number: 1627487-2021-16549, 3006705815-2021-04410.Additional information received indicated the patient's ipg was unable to communicate with external devices.The patient had not recharged the ipg as recommended due to ineffective therapy.Diagnostics confirmed the patient's ipg was inoperable and imaging indicated the patient's leads had migrated.

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, 90CM LENGTH
• Type of Device: PERCUTANEOUS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12377828
• MDR Text Key: 268481549
• Report Number: 1627487-2021-16550
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734401715
• UDI-Public: 05414734401715
• 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: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 3189
• Device Catalogue Number: 3189
• Device Lot Number: 5406101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERCUTANEOUS LEAD; SCS IPG; PERCUTANEOUS LEAD
• Patient Outcome(s): Other
• Patient Age: 49 YR