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

Model Number	3183
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: date of event is unknown.Concomitant medical products and therapy dates: model: 3186, therapy date: unknown.
Event or Problem Description
Device 2 of 2.Reference mfr.Report#: 1627487-2021-01309.It was reported the patient has been receiving ineffective therapy, overstimulation, and discomfort.An impedance check was taken and revealed low impedance on several contacts.Reprogramming was attempted but resolution was unsuccessful.In turn, the patient plans to undergo surgical intervention.
Event or Problem Description
Device 2 of 2 reference mfr.Report#: (b)(4).Additional information obtained revealed surgical intervention took place on (b)(6) 2021.During the procedure the patient's leads were removed, cleaned, and reinserted into their ipg with impedances being within normal range.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Device 2 of 2.Reference mfr.Report#: 1627487-2021-01309.

• Brand Name: OCTRODE LEAD KIT, 30CM LENGTH
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11326107
• Report Number: 1627487-2021-01310
• Device Sequence Number: 728870
• Product Code: LGW
• UDI-Device Identifier: 05414734401692
• UDI-Public: 05414734401692
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2013
• Device Model Number: 3183
• Device Catalogue Number: 3183
• Device Lot Number: 3339577
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 02/24/2021; 03/17/2021
• Initial Report FDA Received Date: 02/14/2021
• Supplement Report FDA Received Date: 03/03/2021; 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other