MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION CINCH LEAD ANCHOR; SCS ANCHOR

Model Number 1194

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

Patient Problems Fever (1858); Swelling (2091); Post Operative Wound Infection (2446)

Event Date 07/03/2019

Event Type  Injury  

Manufacturer Narrative

The device history record was reviewed to ensure proper packaging and sterility.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer reference number: 1627487-2019-08291, related manufacturer reference number: 1627487-2019-08292, related manufacturer reference number: 1627487-2019-08294, related manufacturer reference number: 1627487-2019-08295, related manufacturer reference number: 1627487-2019-08296.It was reported that the patient was experiencing a fever.The physician noticed increased redness, swelling, and pus drainage from the cervical incision, and suspected an infection.It was confirmed that the patient has (b)(6) at both surgical sites.As a result, the patient's entire scs system was explanted.The patient is on intravenous antibiotics for at least six weeks.

• Brand Name: CINCH LEAD 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: 8813226
• MDR Text Key: 151777744
• Report Number: 1627487-2019-08293
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024091
• UDI-Public: 05415067024091
• 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: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2021
• Device Model Number: 1194
• Device Catalogue Number: 1194
• Device Lot Number: 6958116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2019
• 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: SCS ANCHOR; SCS EXTENSION X 2; SCS IPG; SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 93