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

Model Number 3086

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete patient and device information.The unique device identifier (udi #) is unknown because the lot and part number were not provided.

Event Description

It was reported that during the trial procedure on (b)(6) 2021, the trial had to be abandoned due to excessive bleeding.A lateral x-ray was taken and saw the lead was shallow and in the subcutaneous space.No products were implanted.The excessive bleeding has since resolved.

Manufacturer Narrative

The results of the investigation are inconclusive since the lead was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

• Brand Name: OCTRODE TRIAL LEAD KIT, 60CM LENGTH
• Type of Device: SCS TRIAL LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11346246
• MDR Text Key: 232505782
• Report Number: 1627487-2021-01398
• Device Sequence Number: 1
• Product Code: LGW
• 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: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3086
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other