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

Model Number 1192

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

Patient Problems Erythema (1840); Pain (1994); Post Operative Wound Infection (2446)

Event Date 01/10/2019

Event Type  Injury  

Event Description

Device 3 of 3.Reference mfr.Report#3006705815-2019-00442, reference mfr.Report#3006705815-2019-00441.It was reported the patient experienced pain, redness, and warmth around the ipg and lead site.Follow-up identified surgical intervention was undertaken wherein the entire system was explanted due to suspected infection.Reportedly, the patient is being referred to a hospitalist as the next course of action.

Event Description

Device 3 of 3.Reference mfr.Report#3006705815-2019-00442.Reference mfr.Report#3006705815-2019-00441.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS SWIFT LOCK 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: 8299306
• MDR Text Key: 134845194
• Report Number: 1627487-2019-01956
• Device Sequence Number: 1
• Product Code: GZB
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2020
• Device Model Number: 1192
• Device Lot Number: 6491038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2018
• 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): Other
• Patient Weight: 86