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 Problems Swelling (2091); Fluid Discharge (2686)

Event Date 03/12/2019

Event Type  Injury  

Event Description

Device 3 of 5; reference mfr.Report#: 1627487-2019-03989, reference mfr.Report#: 1627487-2019-03990, reference mfr.Report# 1627487-2019-05512, reference mfr.Report#: 3006705815-2019-01738.It was reported the patient experienced swelling, fluid, and redness located at the incision sites.As a result, the patient underwent surgical intervention wherein the scs system was explanted.In turn, the patient was administered oral and iv antibiotics.Reportedly, an infection was ruled out, however the physician is awaiting the results from the second report.The physician referred the patient to another healthcare provider for the next course of action.

• 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: 8608419
• MDR Text Key: 144990569
• Report Number: 1627487-2019-05511
• 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
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Model Number: 1192
• Device Lot Number: 6772662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2019
• Is the Device Single Use?: No
• 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(2), SCS LEAD; MODEL: 3660, SCS IPG
• Patient Outcome(s): Other
• Patient Weight: 54