MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD, 3/4MM, 90 CM; SCS LEAD

Model Number	3149
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.Additional components potentially involved in the event include: common device name: scs octrode lead, model: 3186, udi: (b)(4), serial: (b)(6), batch: 4918711.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
It was reported that the patient's lead eroded through the skin.Surgical intervention was undertaken on (b)(6) 2024 wherein the lead was explanted and replaced to address the issue.Therapy was restored post procedure.Investigation was unable to determine which lead attributed to this issue.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.Additional components potentially involved in the event include: common device name: scs octrode lead, model: 3186, udi: (b)(4), serial: (b)(6), batch: 4918711.

• Brand Name: QUATTRODE LEAD, 3/4MM, 90 CM
• 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: 18743575
• Report Number: 1627487-2024-07077
• Device Sequence Number: 15264789
• Product Code: LGW
• UDI-Device Identifier: 05414734406055
• UDI-Public: 05414734406055
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2024

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: 12/28/2016
• Device Model Number: 3149
• Device Lot Number: 4918711
• 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: Not provided
• Initial Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2014
• 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 IPG; SCS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 73 KG