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

Model Number	3219
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient experienced undesired nerve stimulation with their scs system.In turn, reprogramming was unable to resolve the issue.As a result, surgical intervention may be pending to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.
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.
Event or Problem Description
Related manufacturer report number: 3006705815-2023-04755.Additional information indicates that surgical intervention was undertaken on (b)(6) 2023 wherein the lead was explanted and replaced to address the issue.
Additional Manufacturer Narrative
A patient experiencing ineffective therapy and stimulation sensation regardless of therapy off or on was reported to abbott.The patient experienced undesired nerve stimulation with their scs system.Reprogramming was unable to resolve the issue.The rep identified high impedances on multiple contacts.A review of salesforce showed that a surgical procedure took place on (b)(6) 2023 with replacement of ipg and lead.The ipg was replaced for inability to use stim due to painful stim while in use.In an update posted on 30 jan 2024 it was reported the patient¿s system worsened.The new ipg did not provide any relief.The physician agreed to remove the abbott stimulator completely when they could work in their scheduled.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.
Event or Problem Description
Medwatch form mw5150045 received on 30jan2024 reporting the ipg replacement which happened on (b)(6) 2023.

• Brand Name: LAMITRODE TRIPOLE 16 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: 16885102
• Report Number: 1627487-2023-01994
• Device Sequence Number: 6043311
• Product Code: LGW
• UDI-Device Identifier: 05415067017628
• UDI-Public: 05415067017628
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/26/2024

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: 05/28/2011
• Device Model Number: 3219
• Device Catalogue Number: 3219
• Device Lot Number: 2801817
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 07/11/2023; 08/24/2023; 04/08/2024
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 08/01/2023; 08/31/2023; 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2009
• 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: 45 KG