MAUDE Adverse Event Report: ABBOTT MEDICAL PENTA 3MM LEAD, 60 CM; SCS LEAD

Model Number	3228
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported that patient's system was unable to enter mri mode.Troubleshooting revealed high impedances on the lead.As a result, surgical intervention may be undertaken to address the issue.
Additional Manufacturer Narrative
Correction h6: health impact code should have been 4629 - device revision or replacement instead of 4605 - disruption of subsequent medical procedure.It was reported to abbott during an ipg replacement procedure high impedance was found on contacts 9-16.As the patient need mri, the patient was scheduled for a paddle lead revision.Approximately 3 weeks later the revision took place where the paddle lead with high impedance was explanted and replaced.There were no complications.Effective therapy was restored.The results of the investigation are inconclusive as the device was not returning for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.Date of event and patient's weight is estimated.
Event or Problem Description
Additional information received indicates the lead was replaced on (b)(6) 2025 to address this issue.

• Brand Name: PENTA 3MM LEAD, 60 CM
• 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: sara speyerer ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 23688301
• Report Number: 1627487-2025-05881
• Device Sequence Number: 9584375
• Product Code: LGW
• UDI-Device Identifier: 05414734406246
• UDI-Public: (01)05414734406246(10)4882868(17)161128
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 12/09/2025

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: 11/28/2016
• Device Model Number: 3228
• Device Catalogue Number: 3228
• Device Lot Number: 4882868
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2014
• 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 Age: 48 YR
• Patient Sex: Female
• Patient Weight: 63 KG