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

Model Number 3189

Device Problem Impedance Problem (2950)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)

Event Date 09/29/2023

Event Type  Injury  

Event Description

It was reported that during a follow-up visit it was observed that the impedance had increased on one of the leads.Investigation was unable to determine which lead had the impedance issue.

Manufacturer Narrative

Additional components potentially involved in the event include: common device name: scs lead, model: 3189 , udi:(b)(6), serial: (b)(6), batch:6880059.

Manufacturer Narrative

Per the information available, this event does not meet the reporting criteria.

Event Description

Per the information obtained, during the impedance check on (b)(6) 2023 revealed that the impedance value has increased.No surgical intervention was reported.

• Brand Name: OCTRODE LEAD KIT, 90CM LENGTH
• Type of Device: SCS 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: 18954664
• MDR Text Key: 338305003
• Report Number: 1627487-2024-07681
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734401715
• UDI-Public: 05414734401715
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2020
• Device Model Number: 3189
• Device Lot Number: 6557452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2018
• 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 LEAD
• Patient Outcome(s): Other