MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE 4 LEAD KIT, 60CM LENGTH; SCS PADDLE LEAD

Model Number	3240
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.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 report number: 1627487-2021-14353.It was reported that the patient was not receiving effective adequate therapy from their system.The patient also experienced spasms and uncomfortable stimulation.In turn, surgical intervention was undertaken wherein the system was explanted, resolving the issue.

• Brand Name: LAMITRODE 4 LEAD KIT, 60CM LENGTH
• Common Device Name: SCS PADDLE LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11872111
• Report Number: 1627487-2021-14352
• Device Sequence Number: 11563792
• Product Code: LGW
• UDI-Device Identifier: 05414734402033
• UDI-Public: 05414734402033
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2021

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: 04/22/2022
• Device Model Number: 3240
• Device Catalogue Number: 3240
• Device Lot Number: 7488617
• 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: 05/13/2021
• Initial Report FDA Received Date: 05/24/2021
• 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: 3240, SCS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR