MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROTEGE; SCS IPG

Model Number 3789

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Burning Sensation (2146)

Event Date 10/25/2014

Event Type  Injury  

Event Description

It was reported the patient was admitted to the hospital after experiencing pain at her scs ipg site with stimulation both on and off in addition to fever and fatigue.An sjm representative met with the patient for system diagnostics, but no impedance issues were noted at all lead contacts were within normal limits.Surgical intervention may take place at a later date to address the issue.

Manufacturer Narrative

Sjm has limited information related to the patient's medical history an is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

Manufacturer Narrative

(b)(4).

Event Description

Follow-up information indicated that allergy testing was undertaken and the patient had a nickel allergy.As a result, surgical intervention was undertaken in (b)(6) 2014 (exact date unknown) wherein the entire scs system was explanted.

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete patient information.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• Brand Name: PROTEGE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: logan farmer ; 6901 preston rd.; plano, TX 75024 ; 9725269611
• MDR Report Key: 4283444
• MDR Text Key: 5225620
• Report Number: 1627487-2014-08434
• Device Sequence Number: 1
• Product Code: GZB
• 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,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2016
• Device Model Number: 3789
• Device Lot Number: 4552644
• Other Device ID Number: 054147344005690
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2014
• Initial Date FDA Received: 11/19/2014
• Supplement Dates Manufacturer Received: 04/14/2020; 05/12/2020
• Supplement Dates FDA Received: 05/11/2020; 05/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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 LEAD: MODEL 3228; IMPLANT DATE:
• Patient Outcome(s): Hospitalization
• Patient Age: 45 YR