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

Model Number	3246
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer report numbers: 1627487-2020-33393, 3006705815-2020-32519.It was reported that the patient was experiencing ineffective therapy.Troubleshooting was performed, but the issue persisted.As a result, the patient underwent surgical intervention during which the system was explanted and replaced.Effective therapy was established post-operatively.
Additional Manufacturer Narrative
Correction: section h6 results code 213 and conclusion code 67 in additional report 1 should have been result code 3221 and conclusion code 4315.This correction is reflected in this additional report 2.
Additional Manufacturer Narrative
The reported event for ineffective stimulation could not be confirmed due to general damage/incomplete product.The root cause of damage was consistent with explant damage.

• Brand Name: LAMITRODE S-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: 10802292
• Report Number: 1627487-2020-33394
• Device Sequence Number: 11047235
• Product Code: LGW
• UDI-Device Identifier: 05414734402095
• UDI-Public: 05414734402095
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2020

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: 05/28/2014
• Device Model Number: 3246
• Device Catalogue Number: 3246
• Device Lot Number: 3713558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 12/01/2020; 12/18/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/16/2020; 12/18/2020
• 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 IPG; SCS LEAD; SCS IPG; SCS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Weight: 68