MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE 88 LEAD KIT, 60CM LENGTH; SCS PADDLE LEAD

Model Number 3288

Device Problem Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Event Description

Related manufacturer reference number: 3006705815-2021-04646.It was reported the patients octrode lead displayed high impedance.Surgical intervention was undertaken to address the issue.During the procedure it was determined the patients lamitrode lead was fractured.As a result, the lamitrode and the octrode were explanted and replaced with a single lead.

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 event could not be conclusively determined.

• Brand Name: LAMITRODE 88 LEAD KIT, 60CM LENGTH
• Type of Device: SCS PADDLE LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12501324
• MDR Text Key: 272433670
• Report Number: 1627487-2021-17099
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734402248
• UDI-Public: 05414734402248
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 3288
• Device Catalogue Number: 3288
• Device Lot Number: 5546910
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 09/24/2021
• Supplement Dates FDA Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL: 3186, SCS LEAD
• Patient Outcome(s): Other