MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE 44 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number	3244
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Advance (2524)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event estimated.Unique device identifier (udi #): the udi is unknown because the lot number was not provided.During processing of this incident, attempts were made to obtain complete device information.Further information was requested but not received.
Event or Problem Description
It was reported that the during an ipg replacement surgery, the physician nicked the insulation of the lead when opening the battery pocket.The wire was superficial on top of the battery.The surgical procedure was aborted, and the physician closed the incision.The patient had no therapy at this time.Surgical intervention may take place at a future date to address the issue.
Additional Manufacturer Narrative
Date of event estimated.
Event or Problem Description
Additional information was received stating surgical intervention took place on (b)(6) 2024 where the lead was explanted and replaced to address the issue.Effective stimulation was restored.
Additional Manufacturer Narrative
Date of event estimated.Correction - section d - device info.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 event could not be conclusively determined.

• Brand Name: LAMITRODE 44 LEAD KIT, 60CM LENGTH
• Common Device Name: SCS 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: 19765078
• Report Number: 1627487-2024-09866
• Device Sequence Number: 8624658
• Product Code: LGW
• UDI-Device Identifier: 05414734406215
• UDI-Public: (01)05414734406215(10)26854(17)060331
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2006
• Device Model Number: 3244
• Device Catalogue Number: 3244
• Device Lot Number: 26854
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 08/13/2024; 09/12/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/09/2024; 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 IPG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 73 KG