MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD, 3/4MM, 60 CM; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	3146
Medical Device Problem Codes	Therapeutic or Diagnostic Output Failure (3023); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: event date is estimated.The allegation is against 1 of 3 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: scs quattrode lead, model: 3146, udi: (b)(4), serial:(b)(6), batch:6192219.Common device name: scs octrode percutaneous lead, model: 3186, udi: (b)(4), serial: (b)(6), batch: a000044592.
Event or Problem Description
It was reported that the patient underwent surgical intervention on (b)(6) 2023 in which a trial lead was added due to ineffective stimulation on the patient's right side.Further surgical intervention may be pending.The investigation was not able to determine which lead contributed to this issue.
Event or Problem Description
Additional information received reports that the patient does not have ineffective stimulation and therefore this is no longer reportable.
Additional Manufacturer Narrative
Correction b5: additional information received reports that the patient does not have ineffective stimulation and therefore this is no longer reportable.

• Brand Name: QUATTRODE LEAD, 3/4MM, 60 CM
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: 17618935
• Report Number: 1627487-2023-04040
• Device Sequence Number: 11412725
• Product Code: LGW
• UDI-Device Identifier: 05415067017321
• UDI-Public: 05415067017321
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 09/20/2023

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: 11/09/2019
• Device Model Number: 3146
• Device Lot Number: 6192219
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2017
• 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 ANCHOR (X3); SCS IPG; SCS LEAD (X2)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 63 KG