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

Model Number	3383
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of surgery is unknown.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.
Event or Problem Description
Related manufacturer reference number 1627487-2022-01680.Related manufacturer reference number 3006705815-2022-13630.Related manufacturer reference number 1627487-2022-01984.It was reported that patient underwent surgical intervention at unknown date wherein the extensions, ipg were explanted and the cervical lead tails were cut for unknown reason.Additional surgical intervention may take place to address the issue.

• Brand Name: EXTENSION, 30CM
• Common Device Name: SCS EXTENSION
• 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: 14047921
• Report Number: 1627487-2022-01985
• Device Sequence Number: 5870618
• Product Code: LGW
• UDI-Device Identifier: 05415067017918
• UDI-Public: 05415067017918
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

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: 03/31/2017
• Device Model Number: 3383
• Device Catalogue Number: 3383
• Device Lot Number: 5060519
• 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: 03/18/2022
• Initial Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2015
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 68 KG