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	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant date is unknown.Event and therapy date is estimated.The results/ method and conclusion codes along with the investigation results will be provided in the final report.
Event or Problem Description
Manufacturer report numbers: 1627487-2020-21469, 1627487-2020-21471,1627487-2020-21473.It was reported patient's scs system was explanted due to infection at an unknown place and unknown time.
Additional Manufacturer Narrative
A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.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: CINCH LEAD ANCHOR
• Common Device Name: SCS ANCHOR
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10134061
• Report Number: 1627487-2020-21472
• Device Sequence Number: 14416265
• Product Code: GZB
• UDI-Device Identifier: 05414734400688
• UDI-Public: 05414734400688
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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: 02/28/2014
• Device Model Number: 1194
• Device Catalogue Number: 1194
• Device Lot Number: 3607324
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 08/27/2020
• 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 IPG; SCS LEAD; SCS ANCHOR; SCS IPG; SCS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR