MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION CINCH LEAD ANCHOR; SCS ANCHOR

Model Number	1194
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method, and conclusion codes along with the investigation results will be provided in final report.
Event or Problem Description
Related manufacturer reference number: 1627487-2020-04338.Related manufacturer reference number: 1627487-2020-04339.Related manufacturer reference number: 1627487-2020-04340.Related manufacturer reference number: 1627487-2020-04341.Related manufacturer reference number: 1627487-2020-04342.Related manufacturer reference number: 1627487-2020-04344.Related manufacturer reference number: 1627487-2020-04345.Related manufacturer reference number: 1627487-2020-04346.It was reported that the patients system was explanted on and unknown date due to infection.Patient declined to provide further information.
Additional Manufacturer Narrative
A patient had their system explanted due to infection was reported to abbott.As a result, a device history record was performed to review and confirm the sterility of devices.Based on the documents reviewed, the source of the infection remains unknown.

• Brand Name: CINCH LEAD ANCHOR
• Common Device Name: SCS ANCHOR
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10017655
• Report Number: 1627487-2020-04343
• Device Sequence Number: 11501357
• Product Code: GZB
• UDI-Device Identifier: 05414734400688
• UDI-Public: 05414734400688
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K081208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020

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: 08/28/2011
• Device Model Number: 1194
• Device Catalogue Number: 1194
• Device Lot Number: 2844885
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 05/08/2020
• 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: SCS ANCHOR; SCS ENTENSION (X3); SCS IPG; SCS LEAD (X3)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR