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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION GUARDIAN¿ CRANIAL BURR HOLE COVER SYSTEM; DBS BURR HOLE COVER
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ST. JUDE MEDICAL - NEUROMODULATION GUARDIAN¿ CRANIAL BURR HOLE COVER SYSTEM; DBS BURR HOLE COVER Back to Search Results
Model Number 6010
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Erosion (1750)
Date of Event 01/24/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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.
 
Event or Problem Description
It was reported that the lead accessory was eroding through the skin.As a result, the product was explanted, and a new accessory was implanted.There were no complications during the procedure.Patient was stable.
 
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Brand Name
GUARDIAN¿ CRANIAL BURR HOLE COVER SYSTEM
Common Device Name
DBS BURR HOLE COVER
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key9688818
Report Number1627487-2020-01455
Device Sequence Number3654776
Product Code MHY
UDI-Device Identifier05414734403061
UDI-Public05414734403061
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
P140009
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/10/2020
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 Date07/05/2020
Device Model Number6010
Device Catalogue Number6010
Device Lot Number6520735
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/24/2020
Initial Report FDA Received Date02/10/2020
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;
Patient Weight50
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