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

Model Number	3225
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a lead replacement surgery on (b)(6) 2021 (manufacturer report number 1627487-2021-17986) the lead had high impedances.Surgical intervention may take place at a later date.
Event or Problem Description
Additional information received indicates the patient experienced ineffective stimulation.Surgical intervention took place wherein the lead was explanted and replaced.Effective therapy was established.
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
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 12976023
• Report Number: 1627487-2021-18912
• Device Sequence Number: 4830298
• 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: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2022

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: 10/03/2018
• Device Model Number: 3225
• Device Catalogue Number: 3225
• Device Lot Number: 5662941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 12/13/2021; 01/19/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 12/17/2021; 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCS IPG; SCS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 68 KG