MAUDE Adverse Event Report: ABBOTT MEDICAL EXCLAIM LEAD, 90 CM; SCS LEAD

Model Number	3225
Medical Device Problem Codes	Break (1069); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The date of event is estimated.The results, method and conclusion codes along with the investigation results will be provided in the final report.
Event or Problem Description
It was reported that the patient experienced ineffective stimulation.The patient may undergo surgical intervention to address the issue.
Event or Problem Description
Follow up information received that the patient had the lead explanted and replaced.
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 incident could not be conclusively determined.

• Brand Name: EXCLAIM LEAD, 90 CM
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10826126
• Report Number: 1627487-2020-47713
• Device Sequence Number: 17083738
• Product Code: LGW
• UDI-Device Identifier: 05415067017758
• UDI-Public: 05415067017758
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2021

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: 02/28/2018
• Device Model Number: 3225
• Device Catalogue Number: 3225
• Device Lot Number: 5423683
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 11/24/2020; 02/20/2021
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 12/09/2020; 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 68