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 Meningitis (2389)

Event Date 03/22/2019

Event Type  Injury  

Event Description

Device 2 of 5.Reference mfr.Report#: 3006705815-2019-01309.Reference mfr.Report#: 3006705815-2019-01310.Reference mfr.Report#: 3006705815-2019-01311.Reference mfr.Report#: 1627487-2019-04381.It was reported the patient developed bacterial meningitis and was admitted tot the hospital.In turn, the patient will undergo surgical intervention to address the issue.

Event Description

Device 2 of 5.Reference mfr.Report#: 3006705815-2019-01309.Reference mfr.Report#: 3006705815-2019-01310.Reference mfr.Report#: 3006705815-2019-01311.Reference mfr.Report#: 1627487-2019-04381.

• 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: 8506588
• MDR Text Key: 141719270
• Report Number: 1627487-2019-04380
• Device Sequence Number: 1
• Product Code: LSW
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2020
• Device Model Number: 1192
• Device Lot Number: 6510042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2019
• Initial Date FDA Received: 04/11/2019
• Supplement Dates Manufacturer Received: 06/07/2019
• Supplement Dates FDA Received: 06/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2018
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 41 YR