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U.S. Department of Health and Human Services

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

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ABBOTT MEDICAL DBS CONVENTIONAL IPG; DBS IPG Back to Search Results
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.
 
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Brand Name
DBS CONVENTIONAL IPG
Type of Device
DBS IPG
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key11278355
MDR Text Key230235378
Report Number1627487-2021-00871
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
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 NumberNMD0009
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/19/2021
Initial Date FDA Received02/04/2021
Supplement Dates Manufacturer Received03/31/2021
Supplement Dates FDA Received04/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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