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	Post Operative Wound Infection (2446)
Date of Event	08/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Reference manufacturer number: 3006705815-2020-31489, 1627487-2020-31630, 1627487-2020-31631, 1627487-2020-31633.It was reported the patient was admitted to the hospital and diagnosed with an infection at the ipg site that had spread to the leads.The physician stated that the patient cut their foot a week after their ipg replacement and the infection spread up their foot to their ipg site.The patient was prescribed antibiotics and hospitalized for multiple nights.Note: since it is not known which device contributed to the issue, all possible devices are being reported on.
Additional Manufacturer Narrative
Date of event is estimated.Attempts were made to obtain complete event and patient information.Additional information was not provided.An event of infection was reported to abbott.It was conveyed that the infection originates at the ipg and lead site(s), however, no explanted products were returned for analysis.As a result, a device history record was performed to review and confirm the sterility of the ipg and lead(s).Based on the documents reviewed, the source of the infection remains unknown.

• 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: 10550522
• Report Number: 1627487-2020-31632
• Device Sequence Number: 11080299
• Product Code: GZB
• UDI-Device Identifier: 05415067016621
• UDI-Public: 05415067016621
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

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: 03/31/2017
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 5069950
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 11/17/2020
• 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: 1192, SCS ANCHOR; 3186, SCS LEAD X2; 3660, SCS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 122