MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD WIDE SPACED, 30 CM; SCS LEAD

Model Number	3163
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
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 octrode lead, model: 3186, udi: (b)(4), batch: 2858161.
Event or Problem Description
It was reported that the patient experienced uncomfortable stimulation due to lead migration.Surgical intervention may be undertaken at a later date to address the issue.Investigation was unable to determine which of the leads migrated.
Additional Manufacturer Narrative
Health effect - clinical code correction: it was updated from 1980 to 4582.Health effect - impact code correction: it was updated from 4610 to 4627.Medical device problem code correction: it was updated from 4003 to 2993.
Event or Problem Description
Additional information was received that the lead was electively replaced on (b)(6) 2024 to make the implanted system mri conditional.There is no stated deficiency of the lead.

• Brand Name: QUATTRODE LEAD WIDE SPACED, 30 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: 18659516
• Report Number: 1627487-2024-00656
• Device Sequence Number: 7297942
• Product Code: LGW
• UDI-Device Identifier: 05414734401654
• UDI-Public: 05414734401654
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 03/05/2024

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: 03/28/2011
• Device Model Number: 3163
• Device Lot Number: 2765390
• 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: 01/23/2024
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2009
• 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 IPG
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 95 KG