MAUDE Adverse Event Report: ABBOTT MEDICAL EXTENSION, DUAL 4 CHANNEL 30CM; SCS EXTENSION

Model Number	3343
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of the event is estimated.
Event or Problem Description
Related manufacturer reference number: 1627487-2021-17409, 1627487-2021-17410.It was reported 2 of the patients extensions eroded through the skin causing high impedances.Surgical intervention took place in which the 2 leads were explanted and replaced to address the issue.Eroded area has healed and therapy has been restored.Note: it is unknown which 2 leads eroded; therefore all leads are being reported.
Additional Manufacturer Narrative
Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. .

• Brand Name: EXTENSION, DUAL 4 CHANNEL 30CM
• Common Device Name: SCS EXTENSION
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12562299
• Report Number: 1627487-2021-17408
• Device Sequence Number: 1494662
• Product Code: LGW
• UDI-Device Identifier: 05414734402293
• UDI-Public: 05414734402293
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2021

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: 08/20/2021
• Device Model Number: 3343
• Device Catalogue Number: 3343
• Device Lot Number: 7131202
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 10/09/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 10/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MODEL # 3383 - EXTENSION (X2); MODEL # 3383 - EXTENSION (X2)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Weight: 77