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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date is estimated.
Event or Problem Description
It was reported that the patient's scs paddle lead has impedances.Patient may undergo surgical intervention at a later date to rectify the issue.
Additional Manufacturer Narrative
A system displaying warning message ¿replace generator soon¿ warning message was reported to abbott.It was also determined the lad read high impedance.As a result, the patient¿s ipg and lead were replaced.Therapy was restored.The results of the investigation are inconclusive since the implant was not returned for analysis.Based on the information received, the reported event is consistent with the implant reaching end of service.
Event or Problem Description
Additional information was received indicating that the patient underwent surgical intervention wherein the patient's scs paddle lead was explanted and replaced.Therapy was restored post operatively.

• 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: 16770147
• Report Number: 1627487-2023-01819
• Device Sequence Number: 15052332
• Product Code: LGW
• UDI-Device Identifier: 05414734406154
• UDI-Public: 05414734406154
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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): 07/17/2023

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: 09/28/2010
• Device Model Number: 3214
• Device Catalogue Number: 3214
• Device Lot Number: 173237
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 05/18/2023; 06/23/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 06/13/2023; 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2008
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 54 KG