MAUDE Adverse Event Report: ABBOTT MEDICAL EXCLAIM LEAD, 60 CM; SCS PADDLE LEAD

Model Number	3224
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	11/16/2020
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 high impedance.The patient lost therapy approximately one month ago.As a result, the patient may undergo surgical intervention to address the issue.
Event or Problem Description
Further follow up information received that the patient underwent surgical intervention in which the lead was explanted and two new leads were implanted.
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, 60 CM
• Common Device Name: SCS PADDLE LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11096099
• Report Number: 1627487-2020-49353
• Device Sequence Number: 896798
• Product Code: LGW
• UDI-Device Identifier: 05414734406178
• UDI-Public: 05414734406178
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2021

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: 02/28/2017
• Device Model Number: 3224
• Device Catalogue Number: 3224
• Device Lot Number: 5013626
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 12/22/2020; 01/11/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 01/07/2021; 01/11/2021
• 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: 82