MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD, 3/4MM, 60 CM; SCS LEAD

Model Number	3146
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Further information was requested but not received.The allegation is against 1 of 3 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: octrode lead kit, model: 3186, udi: (b)(4), serial: unknown, batch: 3410773.Common device name: quattrode lead, model: 3146, udi: (b)(4), serial: unknown, batch: 3428646.A patient had their system explanted and replaced due to high impedance was reported to abbott.Therapy was restored.The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.
Event or Problem Description
It was reported that the patient experienced ineffective therapy and was unable to place their system into mri mode.Troubleshooting revealed multiple high impedances.As a result, surgical intervention was undertaken to address the issue and the system was explanted and replaced on (b)(6) 2023.It is unknown which lead has high impedance.

• Brand Name: QUATTRODE LEAD, 3/4MM, 60 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: 17072121
• Report Number: 1627487-2023-02612
• Device Sequence Number: 6095471
• Product Code: LGW
• UDI-Device Identifier: 05415067017321
• UDI-Public: 05415067017321
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• 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): 06/06/2023

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: 11/28/2012
• Device Model Number: 3146
• Device Catalogue Number: 3146
• Device Lot Number: 3250336
• 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: 05/11/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2010
• 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; SCS IPG; SCS LEAD (X2)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 93 KG