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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 Problem 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¿s ipg eroded through the skin. As a result, surgical intervention was undertaken on (b)(6) 2020, wherein the entire system was explanted.
 
Manufacturer Narrative
During processing of this complaint, attempts were made to obtain patient¿s weight. Further information was requested but not received. The results of the investigation are inconclusive since the devices were not returned for analysis. Based on the information received, the cause of the reported event could not be conclusively 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 Key9598413
MDR Text Key175387951
Report Number3006705815-2020-00207
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
Report Date 03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/10/2021
Device Model Number3772
Device Catalogue Number3772
Device Lot NumberA000077002
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 Received03/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2019
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: 01/16/2020 Patient Sequence Number: 1
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