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

Model Number 3189

Device Problem Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Date of event is unknown.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

Manufacturer reference number: 1627487-2020-49380.It was reported that the patient's system was explanted (b)(6) 2020 for an unspecified reason.

Manufacturer Narrative

Analysis of the returned lead found it was returned incomplete.Only the terminal end segment (approx.60cm in length) was returned.The segment had no anomalies, passed continuity from contacts to corresponding bare wires, and passed inter-channel continuity testing.

• 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: 11098044
• MDR Text Key: 224512549
• Report Number: 1627487-2020-49379
• 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,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2019
• Device Model Number: 3189
• Device Catalogue Number: 3189
• Device Lot Number: 5857143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS IPG.
• Patient Outcome(s): Other