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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 Problem Temperature Problem (3022)
Patient Problem Burning Sensation (2146)
Event Date 09/12/2019
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 a mild burning sensation at the ipg site. In turn, surgical intervention was undertaken wherein the ipg was explanted and replaced. Postoperatively, the burning sensation has resolved.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
 
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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 Key9112163
MDR Text Key159875049
Report Number3006705815-2019-03651
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 10/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2017
Device Model Number3789
Device Lot Number4944168
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 Received10/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/19/2015
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: 09/24/2019 Patient Sequence Number: 1
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