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

Model Number 3772

Device Problem Temperature Problem (3022)

Patient Problem Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient was experiencing heating at the ipg site while recharging their device.As a result, surgical intervention took place on (b)(6) 2019 wherein the patient had their ipg explanted.

Manufacturer Narrative

As received, reported event for patient feels burns while charging was not confirmed.The ipg, after being depleted, was able to fully charge and pass auto test.Pocket heating testing while charging was conducted using the returned ipg and le charger for 10 hours using test method 76-0011 and analyses of the test data revealed that the temperature distributions on the ipg surface were within specification as indicated in compliance in the eon mini product requirements specification.No anomaly was observed that would have affected the operation of the ipg or reported event.

Manufacturer Narrative

As received, reported events of "patient feels burns while charging" and "patient feels significant heat at the implantation site of his neurostimulator, outside the recharge time" were not confirmed.The ipg, after being depleted, was able to fully charge and pass auto test.Pocket heating testing while charging, as well as while the ipg was providing stimulation, was conducted using the returned ipg and le charger for 10 hours using test method (b)(4) and analyses of the test data revealed that the temperature distributions on the ipg surface were within specification as indicated in compliance in the eon mini product requirements specification.No anomaly was observed that would have affected the operation of the ipg or reported event.

Event Description

It was reported that the patient was experiencing heating at the ipg site while charging and outside of the recharge time.

• Brand Name: PRODIGY MRI IPG
• Type of Device: SCS IPG
• 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: 9551098
• MDR Text Key: 173709375
• Report Number: 1627487-2019-14373
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017093
• UDI-Public: 05415067017093
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2018
• Device Model Number: 3772
• Device Catalogue Number: 3772
• Device Lot Number: 5391987
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/10/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2016
• 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): Other