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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL - NEUROMODULATION PRODIGY MRI IPG SCS IPG Back to Search Results
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.
 
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Brand NamePRODIGY MRI IPG
Type of DeviceSCS 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 Key9551098
MDR Text Key173709375
Report Number1627487-2019-14373
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received01/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/21/2018
Device Model Number3772
Device Catalogue Number3772
Device Lot Number5391987
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/10/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/06/2020 Patient Sequence Number: 1
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