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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 SYS.; DBS BURR HOLE COVER
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ST. JUDE MEDICAL - NEUROMODULATION GUARDIAN CRANIAL BURR HOLE COVER SYS.; 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 Unspecified Infection (1930)
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported the patient experienced decreased wound healing at the burr hole cover site.Cultures were taken and were positive for cutibacterium.In turn, patient was given iv antibiotics and the product was explanted.The wound has healed.
 
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Brand Name
GUARDIAN CRANIAL BURR HOLE COVER SYS.
Common Device Name
DBS BURR HOLE COVER
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key8119439
Report Number1627487-2018-12458
Device Sequence Number16571691
Product Code GXR
UDI-Device Identifier05414734403061
UDI-Public05414734403061
Combination Product (Y/N)N
Initial Reporter StateKS
Initial Reporter CountryUS
PMA/510(K) Number
K152342
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/30/2018
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 Date10/28/2019
Device Model Number6010
Device Lot Number6186764
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 09/28/2018
Initial Report FDA Received Date11/30/2018
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 Age82 YR
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