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

Model Number	3219
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.During processing of this complaint, attempts were made to obtain patient¿s weight.Further information was requested but not received.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
It was reported that patient experienced ineffective therapy.As a result, surgical intervention was undertaken wherein new lead was implanted to address the issue.Effective therapy was restored post operatively.
Event or Problem Description
It was reported that patient experienced ineffective therapy.As a result, surgical intervention was undertaken on 8 mar 2023 wherein new lead was implanted to address the issue.Effective therapy was restored post operatively.
Additional Manufacturer Narrative
"a patient had ineffective therapy, was reported to abbott.Patient is having a retrial today ((b)(6) 2023).Patient had a system previously implanted, and they could not program anything where the patient felt it with their current lead even up to the maxed out amount of 15ma.It was confirmed it was the lead, not battery.In an update it was reported the patient underwent a procedure on (b)(6) 2022.A paddle lead and ipg were implanted before the case.A retrial was done at a different level that was successful.The doctor put in one percutaneous lead and an eterna ipg.He left the paddle lead and removed the old ipg.The results of the investigation are inconclusive since no products were returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.".

• 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: 16449173
• Report Number: 1627487-2023-00880
• Device Sequence Number: 14852895
• Product Code: LGW
• UDI-Device Identifier: 05415067017628
• UDI-Public: 05415067017628
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 03/24/2023

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: 03/28/2012
• Device Model Number: 3219
• Device Catalogue Number: 3219
• Device Lot Number: 3094246
• 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: 02/09/2023
• Supplement Date Received by Manufacturer: 03/08/2023; 03/19/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 03/09/2023; 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2010
• 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: Male