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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROTÉGÉ MRI IPG SCS IPG

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROTÉGÉ MRI IPG SCS IPG Back to Search Results
Model Number 3771
Device Problem Temperature Problem (3022)
Patient Problem Burning Sensation (2146)
Event Date 02/24/2020
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.
 
Event Description
It was reported that the patient experienced pocket heating. As a result, surgical intervention may be pending.
 
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Brand NamePROTÉGÉ MRI IPG
Type of DeviceSCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key10102886
MDR Text Key193026866
Report Number3006705815-2020-02035
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2017
Device Model Number3771
Device Catalogue Number3771
Device Lot Number5250682
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2015
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: 05/29/2020 Patient Sequence Number: 1
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