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

Model Number	3189
Medical Device Problem Codes	Fracture (1260); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Pain Relief (2388)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.
Event or Problem Description
Additional information indicates, a lead diagnosis was performed and confirmed high impedances across the lead.On (b)(6) 2024 surgical intervention was undertaken wherein the lead was confirmed to be fractured.As a result, the lead was explanted and replaced to address the issue.
Event or Problem Description
It was reported the patient is experiencing ineffective therapy.As a result, surgical intervention may be undertaken to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.

• Brand Name: OCTRODE LEAD KIT, 90CM LENGTH
• Common Device Name: 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: 19532982
• Report Number: 1627487-2024-09293
• Device Sequence Number: 7681102
• Product Code: LGW
• UDI-Device Identifier: 05414734406147
• UDI-Public: (01)05414734406147(10)4591301(17)160528
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2016
• Device Model Number: 3189
• Device Catalogue Number: 3189
• Device Lot Number: 4591301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCS ANCHOR; SCS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 98 KG