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	Undesired Nerve Stimulation (1980)
Date of Event	06/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: date of event is estimated.
Event or Problem Description
Related manufacturer reference number: 3006705815-2023-05904, 1627487-2023-04445, 3006705815-2023-05905.It was reported that patient experienced painful shocking sensation through the body.It was noted by physician that the shocking may be due to another neurological syndrome.Lead diagnostics showed that the peripheral lead had a high impedance on contact 2 and the thoracic lead had high impedances on contact 6 and 7.Surgical intervention may be undertaken to address this issue.
Additional Manufacturer Narrative
Analysis of the 3224-paddle lead found it was damaged during the explant procedure (see images).The paddle (stimulation end of the lead) had been pulled off and all internal wires were pulled out of the paddle and broken.Continuity was checked on the lead body segment, from the bare wires to the terminal end contacts and no opens were found.
Additional Manufacturer Narrative
Section e1 - physician name corrected.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Additional information indicated that surgical intervention was undertaken wherein the system was explanted.

• Brand Name: EXCLAIM LEAD, 60 CM
• Common Device Name: SCS PADDLE 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 17769736
• Report Number: 1627487-2023-04446
• Device Sequence Number: 12412189
• Product Code: LGW
• UDI-Device Identifier: 05414734401876
• UDI-Public: 05414734401876
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• 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): 10/23/2023

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: 03/28/2014
• Device Model Number: 3224
• Device Lot Number: 3632848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/29/2023
• Supplement Date Received by Manufacturer: 09/25/2023; 10/18/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/13/2023; 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2012
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 88 KG