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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 8CH INFINITY DBS LEAD KIT, 30CM, 0.5, B
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ST. JUDE MEDICAL - NEUROMODULATION 8CH INFINITY DBS LEAD KIT, 30CM, 0.5, B Back to Search Results
Model Number 6170
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Edema (1820)
Date of Event 01/23/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported the patient showed an unspecific edema at the tip of the dbs lead implant site.The patient underwent a lumbar puncture to make sure there was no inflammatory process.The results turned out negative.No other intervention was necessary.
 
Event or Problem Description
Follow up information received identified the edema issue persists, but it does not cause any problems.The issue is considered resolved.
 
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Brand Name
8CH INFINITY DBS LEAD KIT, 30CM, 0.5, B
Common Device Name
DBS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key8334004
Report Number1627487-2019-01278
Device Sequence Number62923
Product Code MHY
UDI-Device Identifier05415067020635
UDI-Public05415067020635
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
P140009
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/11/2019
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
Operator of Device Health Professional
Device Expiration Date05/20/2020
Device Model Number6170
Device Lot Number6467113
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 01/23/2019
Supplement Date Received by Manufacturer03/11/2019
Initial Report FDA Received Date02/12/2019
Supplement Report FDA Received Date03/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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