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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL PRODIGY MRI IPG, 16CH, RECHARGEABLE SCS IPG

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ABBOTT MEDICAL 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 Seroma (2069)
Event Date 07/21/2021
Event Type  Injury  
Event Description

It was reported that following an implant procedure on 9jul2021, the patient experienced a seroma at the ipg site. The site was drained initially which was unsuccessful, therefore was reopened and cleaned out. The ipg site is still swollen and sore.

 
Manufacturer Narrative

Date of event - corrected aware date and event date to reflect when the seroma was discovered.

 
Event Description

Additional information revealed that the seroma was first discovered on (b)(6) 2021. The ipg site had been initially been drained on (b)(6) 2021. After the initial draining, the site was further drained and cleaned on (b)(6) 2021 and the ipg was sutured in place. The seroma has since resolved.

 
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Brand NamePRODIGY MRI IPG, 16CH, RECHARGEABLE
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 Key12270157
MDR Text Key264837451
Report Number1627487-2021-16066
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberP010032
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
Report Date 09/22/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3772
Device Catalogue Number3772
Device LOT Number7734318
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 Received09/21/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/11/2020
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: 08/03/2021 Patient Sequence Number: 1
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