MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD, 3/4MM, 90 CM; PERCUTANEOUS LEAD

Model Number	3149
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.The allegation is against 2 of 4 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: scs lead, model: 3149ans, udi: (b)(4), serial: n/a, batch: 3956094.Common device name: scs lead, model: 3169ans, udi: (b)(4), serial: n/a, batch: 4055103.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Related manufacturer reference numbers: 1627487-2022-05484; 1627487-2022-05487.It was reported the patient's ipg failed to establish communication with external devices.A manufacturer representative confirmed the issue and the ipg was deemed inoperable.The patient also experienced ineffective therapy in the supraorbital and occipital regions bilaterally.As a result, surgical intervention occurred wherein the ipg and leads were explanted and replaced to address the issue.The investigation did not determine which of the leads are related to ineffective therapy.

• Brand Name: QUATTRODE LEAD, 3/4MM, 90 CM
• Common Device Name: PERCUTANEOUS 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: 15613131
• Report Number: 1627487-2022-05485
• Device Sequence Number: 12748124
• Product Code: LGW
• UDI-Device Identifier: 05414734401593
• UDI-Public: 05414734401593
• 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: 2015
• Device Explanted Year: 2022
• 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): 10/16/2022

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: 02/28/2015
• Device Model Number: 3149
• Device Catalogue Number: 3149
• Device Lot Number: 3956094
• 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: 09/20/2022
• Initial Report FDA Received Date: 10/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2013
• 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 X2; SCS EXTENSION X2; SCS LEAD X2
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 84 KG