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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.
 
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Brand NameDBS CONVENTIONAL IPG
Type of DeviceDBS 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 Key11278355
MDR Text Key230235378
Report Number1627487-2021-00871
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNMD0009
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 Received03/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/04/2021 Patient Sequence Number: 1
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