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 Fever (1858); Irritation (1941); Post Operative Wound Infection (2446)

Event Date 10/08/2018

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 5 of 5: reference mfr.Report: 3006705815-2018-02625, reference mfr.Report: 1627487-2018-10102, reference mfr.Report: 3006705815-2018-02626, reference mfr.Report: 3006705815-2018-02627.It was reported the patient presented to the emergency room with a fever, hives and irritation at both the ipg and lead incision sites.Cultures confirmed an infection at the lead sites.The patient was placed on intra-venous antibiotics and a picc line was inserted.The patient was discharged from the hospital on (b)(6) 2018.The lead incision site has reportedly been healing.Further clarification indicated the ipg site was bruised and tender to the touch.

Event Description

Device 5 of 5: reference mfr.Report: 3006705815-2018-02625, reference mfr.Report: 1627487-2018-10102 , reference mfr.Report: 3006705815-2018-02626, reference mfr.Report: 3006705815-2018-02627.Follow-up identified the patient was seen by the physician.Intravenous antibiotics will be administered for a few more weeks.Surgical intervention is not planned at this time.In addition, there was no tenderness or drainage noted at the incision site.

Event Description

Device 5 of 5.Reference mfr.Report: 3006705815-2018-02625.Reference mfr.Report: 1627487-2018-10102.Reference mfr.Report: 3006705815-2018-02626.Reference mfr.Report: 3006705815-2018-02627.It was reported during follow up that the issue has resolved following antibiotic administration.

• 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: palka sharma ; 6901 preston road; plano, TX 75024 ; 9725264823
• MDR Report Key: 8001802
• MDR Text Key: 124889725
• Report Number: 1627487-2018-10103
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• 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: 6499042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2018
• 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): Hospitalization
• Patient Weight: 71