MAUDE Adverse Event Report: ABBOTT MEDICAL EXTENSION, 30CM; SCS EXTENSION

Model Number 3383

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/04/2023

Event Type  Injury  

Manufacturer Narrative

B3-date of event is estimated.It was reported to abbott, a patient underwent a revision due to a loss of stimulation.When tested alone, the lead did not display any impedance issues.The issue was isolated to the extension which was replaced.Effective therapy was restored.The device was not returned for evaluation as it remains implanted and functioning as intended.Based on the information received, the cause of the reported issue was determined not to be product related.

Event Description

It was reported that the patient was experiencing ineffective therapy from their system.In turn, surgical intervention was undertaken wherein the extension was explanted and replaced.Postoperatively, the patient has effective therapy.

• Brand Name: EXTENSION, 30CM
• Type of Device: SCS EXTENSION
• 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: 18373498
• MDR Text Key: 331112808
• Report Number: 1627487-2023-06046
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734402323
• UDI-Public: 05414734402323
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K960728
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2024
• Device Model Number: 3383
• Device Lot Number: 8263598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• 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