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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROTEGE IPG, 16-CHANNEL RECHARGEABLE SCS IPG

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROTEGE IPG, 16-CHANNEL RECHARGEABLE SCS IPG Back to Search Results
Model Number 3789
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Temperature Problem (3022)
Patient Problems Device Overstimulation of Tissue (1991); Burning Sensation (2146)
Event Date 03/10/2020
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated. The results/method and conclusion codes along with investigation results will be provided on the final report.
 
Event Description
It was reported that patient experienced an uncomfortable shocking sensation at the implantable pulse generator (ipg) site resulting in the patient losing stimulation as well. Impedance was at a normal range and the uncomfortable shocking sensation occurs when the patient last charged the device. Programming changes were made the shocking sensation issue was resolved. Patient called on a later date and stated having a burning sensation at the ipg site despite programming changes being made. It was recommended to turn of therapy and not to lay on the charging antenna while charging the device however the issue was not resolved. Device was explanted, and a new device was implanted. There were no complications during the procedure. Patient was stable.
 
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Brand NamePROTEGE IPG, 16-CHANNEL RECHARGEABLE
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 Key10439860
MDR Text Key203985258
Report Number3006705815-2020-30866
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2017
Device Model Number3789
Device Catalogue Number3789
Device Lot Number4989614
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/24/2015
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: 08/21/2020 Patient Sequence Number: 1
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