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

Model Number 1194

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

Patient Problems Fever (1858); Nausea (1970); Chills (2191)

Event Date 06/10/2019

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.During processing of this complaint, attempts were made to obtain complete patient information.Further information was requested but not received.

Event Description

Reference manufacturer numbers: 3006705815-2019-02669, 3006705815-2019-02670.It was reported the patient presented to the er on (b)(6) 2019 due to experiencing fever, chills, and nausea symptoms which began approximately 3 weeks prior to seeking medical evaluation.It was reported that the patient had been picking at the healed incisions, causing a hole to form at their right midline incision site.Per the patient's request, the physician opted to explant the entire system on (b)(6) 2019.In addition, labs were drawn and levels were within normal range.Cultures were obtained; however, results are unavailable at this time.Postoperatively, the patient was treated with iv antibiotics for one day.There were no visible sign of infection; therefore, the patient was not prescribed oral antibiotics upon discharge.

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.

• Brand Name: CINCH LEAD ANCHOR
• Type of Device: SCS CINCH 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: 8818046
• MDR Text Key: 151933735
• Report Number: 1627487-2019-08114
• 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: K081208
• 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: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2021
• Device Model Number: 1194
• Device Catalogue Number: 1194
• Device Lot Number: 6858809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2019
• 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: MODEL 3186, SCS LEAD; MODEL 3186, SCS LEAD; MODEL 3662, SCS IPG
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 34 YR