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

Model Number 1192

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

Device 5 of 5.Reference mfr.Report: 3006705815-2018-03251, reference mfr.Report: 1627487-2018-12808, reference mfr.Report: 3006705815-2018-03252, reference mfr.Report: 3006705815-2018-03253.It was reported the patient¿s wounds were red and swollen.It was discovered the patient had an infection.As a result, the patient¿s scs system was explanted.

Event Description

Device 5 of 5.Reference mfr.Report: 3006705815-2018-03251.Reference mfr.Report: 1627487-2018-12808.Reference mfr.Report: 3006705815-2018-03252.Reference mfr.Report: 3006705815-2018-03253.Follow-up information provided the patient had vancomycin and tetracycline.Infection has been resolved.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8148314
• MDR Text Key: 129829234
• Report Number: 1627487-2018-12809
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734400671
• UDI-Public: 05414734400671
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2020
• Device Model Number: 1192
• Device Lot Number: 6538983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MODEL 1192, SCS ANCHOR; MODEL 3186 (X2), SCS LEAD; MODEL 3662, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 131