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

Model Number 3189

Device Problem Low impedance (2285)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/23/2023

Event Type  Injury  

Manufacturer Narrative

Section b3: date of event is estimated.

Event Description

Related manufacturer reference number: 1627487-2024-07377.It was reported that patient's cervical system provided ineffective therapy.It was noted that patient has had slips and falls.Reprogramming was attempted to no avail as patient only had right side coverage and not left side coverage.Lead diagnostics showed that 15 out of 16 contacts had low impedances.Surgical intervention may be undertaken to address this issue.

Manufacturer Narrative

Manufacturing reference number 1627487-2024-07378 should not have been reported as a medical device report (mdr) as surgical intervention was not taken on the leads and is no longer reportable.

Event Description

Additional information indicated that programming restored effective therapy and surgical intervention won't be taken on the leads.

• Brand Name: OCTRODE LEAD KIT, 90CM LENGTH
• Type of Device: SCS 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18843208
• MDR Text Key: 336958701
• Report Number: 1627487-2024-07378
• 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: 04/07/2024

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: 04/26/2019
• Device Model Number: 3189
• Device Lot Number: 5951880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 04/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2017
• 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 ANCHOR (2).; SCS IPG (1).
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 79 KG