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

Model Number	3228
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	08/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's lead eroded through the skin.Surgical intervention may be undertaken to address the issue.It is unknown which lead or extension is at fault.
Additional Manufacturer Narrative
The date of event is estimated.The allegation is against 1 of 5 leads / 2 extensions; however, it is unknown which product; therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: quattrode lead wide spaced, 30 cm, model: 3163, udi: (b)(4), batch: 3773645.Common device name: quattrode lead wide spaced, 30 cm, model: 3163, udi: (b)(4), batch: 3773645.Common device name: quattrode lead wide spaced, 60 cm, model: 3166, udi: (b)(4), batch: 3773643.Common device name: quattrode lead wide spaced, 60 cm, model: 3166, udi: (b)(4), batch: 3571569.Common device name: extension, dual 4 channel 10cm, model: 3341, udi: (b)(4), batch: 3491206.Common device name: extension, dual 4 channel 10cm, model: 3341, udi: (b)(4), batch: 3729997.
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.

• 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: 23043581
• Report Number: 1627487-2025-04540
• Device Sequence Number: 9477272
• Product Code: LGW
• UDI-Device Identifier: 05414734401913
• UDI-Public: (01)05414734401913(10)3467811(17)130828
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 11/17/2025

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: 08/28/2013
• Device Model Number: 3228
• Device Catalogue Number: 3228
• Device Lot Number: 3467811
• 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: 08/23/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2011
• 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 EXTENSION (X2); SCS IPG (X2); SCS LEAD (X4)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female