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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL PRODIGY IPG SCS IPG

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ABBOTT MEDICAL PRODIGY IPG SCS IPG Back to Search Results
Model Number 3799
Device Problem Temperature Problem (3022)
Patient Problem Burning Sensation (2146)
Event Date 04/06/2021
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.
 
Event Description
It was reported that patient experienced discomfort and pocket heating sensation when device therapy remains on. Device therapy was turned off and patient reported some perceived improvement. A surgical intervention is anticipated in the near future. No additional information is available at this time.
 
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Brand NamePRODIGY IPG
Type of DeviceSCS IPG
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer Contact
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key11742423
MDR Text Key247910967
Report Number1627487-2021-13523
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2017
Device Model Number3799
Device Catalogue Number3799
Device Lot Number5196858
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 Received05/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/17/2014
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: 04/28/2021 Patient Sequence Number: 1
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