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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PRODIGY MRI IPG, 16CH, RECHARGEABLE SCS IPG Back to Search Results
Model Number 3772
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Itching Sensation (1943); Skin Erosion (2075)
Event Date 01/03/2020
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 patient experienced redness and itchiness at ipg site and ipg is coming through the skin. Surgical intervention may occur to address the issue.
 
Manufacturer Narrative
Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
 
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Brand NamePRODIGY MRI IPG, 16CH, 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 Key9625179
MDR Text Key176238942
Report Number3006705815-2020-00217
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 consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/22/2021
Device Model Number3772
Device Catalogue Number3772
Device Lot NumberA000078853
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 Received07/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/23/2019
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: 01/23/2020 Patient Sequence Number: 1
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