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

Model Number 3186

Device Problems Fracture (1260); High impedance (1291); Low impedance (2285)

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

Event Date 06/21/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer reference number: 1627487-2021-15467.It was reported the patient is experiencing high and low impedances on the leads.Surgical intervention may take place at a later date.

Event Description

Additional information received indicates the lead was fractured.Surgical intervention took place wherein one lead was explanted and replaced.Therapy was restored.

Manufacturer Narrative

E1 - initial reporter.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: PERCUTANEOUS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12143667
• MDR Text Key: 260747790
• Report Number: 1627487-2021-15468
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734401708
• UDI-Public: 05414734401708
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2014
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: 3710356
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 3186 LEAD; MODEL 3186 LEAD
• Patient Outcome(s): Other
• Patient Weight: 91