MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD KIT, 30CM LENGTH; PERCUTANEOUS LEAD

Model Number	3183
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure, the physician explanted the lead for suspicion of an infection.Patient will be evaluated and put on a course of antibiotics to address the issue.Extension remains implanted.
Additional Manufacturer Narrative
Date of event is estimated.The allegation is against 1 of 2 leads; however, it is unknown which leads, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: lead, model: 3183, udi: (b)(4), batch: 3057083.
Event or Problem Description
Additional information received the patient was put on antibiotics and cultures came back negative.

• Brand Name: OCTRODE LEAD KIT, 30CM LENGTH
• Common Device Name: 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15459824
• Report Number: 1627487-2022-04786
• Device Sequence Number: 6005979
• Product Code: LGW
• UDI-Device Identifier: 05414734401692
• UDI-Public: 05414734401692
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 12/13/2022

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: 11/28/2014
• Device Model Number: 3183
• Device Catalogue Number: 3183
• Device Lot Number: 3861997
• 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: 08/30/2022
• Supplement Date Received by Manufacturer: 10/31/2022; 12/12/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 11/22/2022; 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2012
• 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 ANCHORS; SCS ANCHORSX2; SCS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 66 KG