MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD WIDE SPACED, 90 CM; SCS LEAD

Model Number	3169
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Further information has been requested but not yet received.Additional components potentially involved in the event include: common device name: quattrode lead, model: 3169, udi: (b)(4), batch: 3615842.Common device name: quattrode lead, model: 3166, udi: (b)(4), batch: 3627362.Common device name: quattrode lead, model: 3166, udi:(b)(4), batch: 3627362.Common device name: quattrode lead, model: 3166, udi: (b)(4), batch: 4081179.Common device name: quattrode lead, model: 3166, udi: (b)(4) , batch: 4046673.
Event or Problem Description
It was reported that patient experienced ineffective therapy, patients leads had shifted.As a result, surgical intervention was undertaken on (b)(6) 2023 wherein both of patients systems were explanted and replaced to address the issue.It is unknown which leads shifted.
Event or Problem Description
Related manufacturer reference number: 1627487-2024-00167.Related manufacturer reference number: 1627487-2024-00170.Related manufacturer reference number: 1627487-2024-00172.Related manufacturer reference number: 1627487-2024-00173.Related manufacturer reference number: 1627487-2024-00174.Additional information indicates all of the patients leads had shifted.
Additional Manufacturer Narrative
The results of the investigation are inconclusive 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.

• Brand Name: QUATTRODE LEAD WIDE SPACED, 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: 18297276
• Report Number: 1627487-2023-05862
• Device Sequence Number: 20692672
• Product Code: LGW
• UDI-Device Identifier: 05414734406116
• UDI-Public: 05414734406116
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2023
• 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): 02/06/2024

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: 11/28/2012
• Device Model Number: 3169
• Device Lot Number: 3254416
• 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: 11/16/2023
• Supplement Date Received by Manufacturer: 12/22/2023; 01/30/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/09/2024; 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2010
• 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 (X2).; SCS EXTENSION.; SCS IPG.; SCS IPG.; SCS LEAD (X4).; SCS LEAD.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 91 KG