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

Model Number 3186

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete event and patient information.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 1627487-2020-47729.It was reported that the patient had their lead was explanted and a different type of lead was implanted.

Manufacturer Narrative

Further review indicated manufacturer report number 1627487-2020-47730, should not have been reported as a medical device report (mdr) as the device was found to have been electively removed during a surgical procedure which was unrelated to the device.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10836662
• MDR Text Key: 216138036
• Report Number: 1627487-2020-47730
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• 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
• Report Date: 11/30/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2021
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000075392
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 11/10/2020
• Supplement Dates FDA Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL: 3186; MODEL: 3186
• Patient Outcome(s): Other