MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD, 3/4MM, 90 CM; SCS 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	03/05/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event and therapy dates are estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer reference numbers: 1627487-2021-13162, 1627487-2021-13164, 1627487-2021-13165, 1627487-2021-13166, 1627487-2021-13167, 1627487-2021-13168.It was reported that effective therapy was never established for the patient.As a result surgery may occur to address the issue.
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain patient weight.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
Additional information was received that surgery occurred in which the patient's system was explanted to address the issue.

• Brand Name: QUATTRODE LEAD, 3/4MM, 90 CM
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11662545
• Report Number: 1627487-2021-13163
• Device Sequence Number: 14227530
• 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: 2012
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2021

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: 01/28/2014
• Device Model Number: 3149
• Device Catalogue Number: 3149
• Device Lot Number: 3593570
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 07/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCS EXTENSION (2); SCS IPG; SCS LEAD (3); SCS EXTENSION (2); SCS IPG; SCS LEAD (3)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR