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

Model Number 3189

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with the investigation results will be provided in the final report.

Event Description

Manufacturer report reference number: 1627487-2020-48501, 1627487-2020-48502.It was reported that while the patient was undergoing a surgical intervention due to shocking at the ipg site (manufacturer report reference number: 1627487-2020-48503, 1627487-2020-48504) and lead migration (manufacturer report reference number: 1627487-2020-47815, 3006705815-2020-32723, 1627487-2020-47816, 3006705815-2020-32724), the patient began bleeding profusely.The patient had been off anticoagulant for approximately 48 hours but the surgeon did not feel it was long enough due to the amount of bleeding.The bleeding did cease post operatively.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

Event Description

Follow up information received that the patient's bleeding issue is resolved.

• 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: 10938330
• MDR Text Key: 219307315
• Report Number: 1627487-2020-48500
• 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
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2020
• Device Model Number: 3189
• Device Catalogue Number: 3189
• Device Lot Number: 6445071
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 3189, SCS LEAD; MODEL 3662, SCS IPG; MODEL 3189, SCS LEAD; MODEL 3662, SCS IPG
• Patient Outcome(s): Other
• Patient Weight: 118