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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PRODIGY MRI IPG, 16CH, RECHARGEABLE SCS IPG

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ST. JUDE MEDICAL - NEUROMODULATION PRODIGY MRI IPG, 16CH, RECHARGEABLE SCS IPG Back to Search Results
Model Number 3772
Device Problems Charging Problem (2892); Temperature Problem (3022); Wireless Communication Problem (3283)
Patient Problems Discomfort (2330); Inadequate Pain Relief (2388)
Event Date 01/18/2020
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated. During processing of this complaint, attempts were made to obtain complete event information. The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported the patient experienced a heating sensation at the ipg site. The patient experienced difficulty charging the ipg over the course of a week, and it therefore became inoperable. To address the issue, the patient may be awaiting surgical intervention.
 
Event Description
Follow up information identified the patient experienced heating at the ipg site while charging the ipg.
 
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Brand NamePRODIGY MRI IPG, 16CH, RECHARGEABLE
Type of DeviceSCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key9789139
MDR Text Key182042980
Report Number1627487-2020-02275
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/24/2019
Device Model Number3772
Device Catalogue Number3772
Device Lot Number6173499
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 03/04/2020 Patient Sequence Number: 1
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