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 Unspecified Infection (1930); Swelling (2091)

Event Date 10/30/2018

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Device 5 of 5.Reference mfr.Report# 3006705815-2019-00010, reference mfr.Report# 3006705815-2019-00011, reference mfr.Report# 1627487-2019-00032, reference mfr.Report# 1627487-2019-00033.It was reported the patient experienced blistering located at the ipg and lead sites due to an infection.In turn, the patient was prescribed antibiotics.However, the issue persisted and the physician opted to explant the system.Reportedly, the patient underwent surgical intervention wherein the scs system was explanted.The infection was healed post explant.

Manufacturer Narrative

Corrected data: method, results, and conclusion codes were unintendedly excluded in the initial report.This report contains missing data.

Event Description

Device 5 of 5 : reference mfr.Report# 3006705815-2019-00010 , reference mfr.Report# 3006705815-2019-00011 , reference mfr.Report# 1627487-2019-00032 , reference mfr.Report# 1627487-2019-00033.

Manufacturer Narrative

Awareness date was unintendedly listed incorrect in the supplemental report.It should read dec 21, 2018 instead of dec 11, 2018.

Event Description

Device 5 of 5; reference mfr.Report# 3006705815-2019-00010, reference mfr.Report# 3006705815-2019-00011, reference mfr.Report# 1627487-2019-00032, reference mfr.Report# 1627487-2019-00033.

• 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: 8218669
• MDR Text Key: 132118894
• Report Number: 1627487-2019-00034
• 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: K092371
• 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,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2020
• Device Model Number: 1192
• Device Lot Number: 6383491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2018
• 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 (2), SCS LEADS; MODEL 3662, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 91