MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD KIT, 30CM LENGTH; PERCUTANEOUS LEAD

Model Number	3183
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 event could not be conclusively determined.During processing of this complaint, attempts were made to obtain complete device, patient and event information.
Event or Problem Description
Related manufacturer reference number: 1627487-2021-15927.It was reported the patient experienced inadequate stimulation with their scs system, and stopped using their system.As a result, surgical intervention was undertaken wherein the entire system was explanted.

• Brand Name: OCTRODE LEAD KIT, 30CM LENGTH
• Common Device Name: PERCUTANEOUS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12238238
• Report Number: 1627487-2021-15926
• Device Sequence Number: 3841570
• Product Code: LGW
• UDI-Device Identifier: 05414734401692
• UDI-Public: 05414734401692
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

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: 01/28/2016
• Device Model Number: 3183
• Device Catalogue Number: 3183
• Device Lot Number: 4444442
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 07/28/2021
• 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: 3183, PERCUTANEOUS LEAD
• Outcome Attributed to Adverse Event: Other