MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE 4 LEAD KIT, 60CM LENGTH; SCS PADDLE LEAD

Model Number	3240
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	11/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Additional components potentially involved in the event include: common device name: scs lead, model: 3240, udi: (b)(4), serial:n/a, batch:5636036.
Event or Problem Description
It was reported that the patient experienced ineffective therapy due to high impedance on one of the occipital leads.As such, surgical intervention may take place at a later date to address the issue.Investigation was unable to determine which of the leads attributed to the event.
Event or Problem Description
Additional information received indicates that surgical intervention took place where in the left lead was explanted and replaced to address the issue.Reportedly, therapy was confirmed post op.
Additional Manufacturer Narrative
The reported event of ineffective stimulation was confirmed.As received, the lamitrode lead had all three internal wires broken, that would cause high impedance and is consistent with an overstress condition or sudden event the lead was subjected while in vivo.

• Brand Name: LAMITRODE 4 LEAD KIT, 60CM LENGTH
• Common Device Name: SCS PADDLE 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: 15933752
• Report Number: 1627487-2022-06687
• Device Sequence Number: 20473675
• Product Code: LGW
• UDI-Device Identifier: 05414734402033
• UDI-Public: 05414734402033
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 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): 03/09/2023

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: 09/12/2018
• Device Model Number: 3240
• Device Catalogue Number: 3240
• Device Lot Number: 5636036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/15/2022
• Supplement Date Received by Manufacturer: 12/16/2022; 02/23/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 01/10/2023; 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2016
• 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 EXTENSION (X2).; SCS IPG.; SCS LEAD (X3).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 59 KG