MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE TRIPOLE 16C LEAD, 60 CM; SCS PADDLE LEAD

Model Number	3214
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Initial reporter phone number: (b)(6).
Event or Problem Description
It was reported that the patient's system was autoreducing due to high impedances.Reprogramming was unable to resolve the issue.As a result, the patient underwent surgical intervention during which the lead was explanted and replaced, resolving the issue.
Additional Manufacturer Narrative
The report of high impedance was confirmed.Analysis of the returned lead found two broken wires at channels 3 and 9.These broken wires are consistent with an overstress condition or sudden event the lead was subjected to while still in vivo.

• Brand Name: LAMITRODE TRIPOLE 16C 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16542713
• Report Number: 1627487-2023-01118
• Device Sequence Number: 12375189
• Product Code: LGW
• UDI-Device Identifier: 05414734401784
• UDI-Public: 05414734401784
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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: 12/06/2023
• Device Model Number: 3214
• Device Catalogue Number: 3214
• Device Lot Number: 8242939
• 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: 02/26/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2021
• 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 EXTENSION (X2)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown