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

Model Number 3189

Device Problems Fracture (1260); High impedance (1291)

Patient Problems Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2021

Event Type  Injury  

Manufacturer Narrative

Date of event and therapy date are estimated.

Event Description

Related manufacturer reference number: 1627487-2021-16450.It was reported that during an ipg replacement surgical procedure that occurred on (b)(6) 2021 (documented in manufacturer report 1627487-2021-16446), high impedances were measured on each electrode of one of the patient's leads.As a result, surgery may occur to address the issue.It is unknown which lead had the high impedances, so both applicable leads are being reported.

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 was received that surgery occurred during which the lead was explanted and replaced, which which resolved the issue.A lead fracture was confirmed after the lead was explanted.

• Brand Name: OCTRODE LEAD KIT, 90CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12349348
• MDR Text Key: 267514348
• Report Number: 1627487-2021-16451
• 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: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2014
• Device Model Number: 3189
• Device Catalogue Number: 3189
• Device Lot Number: 3605753
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS LEAD; SCS LEAD
• Patient Outcome(s): Other
• Patient Weight: 73