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

Model Number	3225
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported the patient experienced ineffective therapy due to autoreducing.Diagnostics revealed all contacts have high impedance.X-ray imaging discovered a potential lead fracture or migration.In turn, surgical intervention may take place at a later date to address the issue.
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.
Additional Manufacturer Narrative
A patient experiencing autoreducing due to high impedance was reported to abbott.The patient¿s lead was explanted and replaced.Therapy was restored.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.
Event or Problem Description
Additional information was received stating that the patient lead was explanted and replaced on (b)(6) 2021.The physician noted that the lead was fractured.Effective therapy was established post-op.

• 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: 10807021
• Report Number: 1627487-2020-33454
• Device Sequence Number: 14327987
• Product Code: LGW
• UDI-Device Identifier: 05415067017758
• UDI-Public: 05415067017758
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/26/2021

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: 11/09/2018
• Device Model Number: 3225
• Device Catalogue Number: 3225
• Device Lot Number: 5717972
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 12/11/2020; 03/23/2021; 05/26/2021
• Initial Report FDA Received Date: 11/08/2020
• Supplement Report FDA Received Date: 12/17/2020; 04/09/2021; 05/26/2021
• 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: 102