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

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.

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.

• Brand Name: PRODIGY MRI IPG, 16CH, RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12270157
• MDR Text Key: 264837451
• Report Number: 1627487-2021-16066
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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 Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2022
• Device Model Number: 3772
• Device Catalogue Number: 3772
• Device Lot Number: 7734318
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other