MAUDE Adverse Event Report: ABBOTT MEDICAL DBS CONVENTIONAL IPG; DBS IPG

Model Number NMD0009

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seroma (2069)

Event Type  Injury  

Event Description

This event is being filed to report a post implant seroma that formed over the dbs ipg site.To resolve the issue surgical intervention was undertaken on an unknown date to extract the seroma resolving the issue.The device remains implanted.This event was captured within a literature review.

Manufacturer Narrative

A patient experiencing post operative seroma at the ipg site was reported to abbott.To resolve the issue surgical intervention was undertaken on an unknown date to extract the seroma resolving the issue.Therapy was restored.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: DBS CONVENTIONAL IPG
• Type of Device: DBS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11278355
• MDR Text Key: 230235378
• Report Number: 1627487-2021-00871
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NMD0009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other