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 number: 1627487-2020-33394, 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
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: 10802288
• Report Number: 1627487-2020-33393
• Device Sequence Number: 1137944
• 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
• Report Date (Section B): 12/15/2020

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: 03/28/2014
• Device Model Number: 3246
• Device Catalogue Number: 3246
• Device Lot Number: 3646047
• 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
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/16/2020
• 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