MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION SWIFT-LOCK ANCHOR; SCS ANCHOR

Model Number	1192
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Device 4 of 5.Reference mfr.Report#: 3006705815-2019-00758, reference mfr.Report#:1627487-2019-02813, reference mfr.Report#:1627487-2019-02814, reference mfr.Report#:1627487-2019-02816.It was reported that the patient experienced an infection.As a result, the patient's system was explanted in (b)(6) 2017 (the exact date of explant is unknown).It was unknown if the infection was resolved, however the patient had (b)(6) during the scs re-implantation.
Event or Problem Description
Device 4 of 5.Reference mfr.Report#: 3006705815-2019-00758.Reference mfr.Report#:1627487-2019-02813.Reference mfr.Report#:1627487-2019-02814.Reference mfr.Report#:1627487-2019-02816.

• Brand Name: SWIFT-LOCK ANCHOR
• Common Device Name: SCS ANCHOR
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 8378481
• Report Number: 1627487-2019-02815
• Device Sequence Number: 18918502
• Product Code: GZB
• UDI-Device Identifier: 05415067016621
• UDI-Public: 05415067016621
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K092371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2019

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: 06/30/2017
• Device Model Number: 1192
• Device Lot Number: 5164318
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 04/03/2019
• 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: 1192, SCS ANCHOR; MODEL: 3186(2), SCS LEAD; MODEL: 3771, SCS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 73