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

Model Number	3225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Attempts were made to obtain complete event and patient information.Additional information was not provided.The results/method and conclusion codes along with investigation results will be provided in the final report.It was reported the abbott care team called a patient who stated their system had been explanted.The patient stated their body rejected the implant.No additional information was provided.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
Reference manufacturer number: 3006705815-2020-33390.It was reported that the patient's body rejected their scs system likely due to an allergic response.In turn, the patient underwent surgical intervention wherein the devices were explanted on an unknown date to address the issue.Note: since it is not known which device contributed to the issue, all possible devices are being reported on.

• Brand Name: EXCLAIM LEAD, 90 CM
• Common Device Name: SCS PADDLE LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11065821
• Report Number: 1627487-2020-49174
• Device Sequence Number: 2610376
• Product Code: LGW
• UDI-Device Identifier: 05415067017758
• UDI-Public: 05415067017758
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/23/2020

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: 01/31/2017
• Device Model Number: 3225
• Device Catalogue Number: 3225
• Device Lot Number: 4994976
• 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: 12/10/2020
• Initial Report FDA Received Date: 12/23/2020
• 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: MODEL 3771, SCS IPG
• Outcome Attributed to Adverse Event: Other