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

Model Number 3189

Device Problem Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/16/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The allegation is against 1 of 2 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: scs octrode percutaneous lead, model: 3189, udi: (b)(4), serial: (b)(4), batch: 6151980.

Event Description

Related manufacturer reference number: 1627487-2022-03787.It was reported the patient had an unrelated surgery where the ipg was not placed in surgery mode.Subsequently, the patient has been unable to connect to the ipg.Troubleshooting was attempted by a company representative to no avail.One lead was noted to be fractured.Surgical intervention took place wherein the ipg and one lead was explanted and replaced to address the issue.

Manufacturer Narrative

A patient had an unrelated surgery where the ipg was not placed in surgery mode.Subsequently, the patient has been unable to connect to the ipg.Troubleshooting was attempted by a company representative to no avail.One lead was noted to be fractured.As a result, the ipg and one lead was explanted and replaced to address the issue.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: OCTRODE LEAD KIT, 90CM LENGTH
• Type of Device: PERCUTANEOUS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 14956231
• MDR Text Key: 295487228
• Report Number: 1627487-2022-03788
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734401715
• UDI-Public: 05414734401715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2019
• Device Model Number: 3189
• Device Catalogue Number: 3189
• Device Lot Number: 5949159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCS ANCHORS X 2
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 107 KG