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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 No Consequences Or Impact To Patient (2199)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event or Problem Description
It was reported that the patient's (b)(6) lead had been incorrectly placed.As a result, the lead was explanted and replaced with two new leads.
 
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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 Key8182799
Report Number1627487-2018-13287
Device Sequence Number11063673
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
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 05/06/2019
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 Date12/08/2019
Device Model Number6170
Device Catalogue Number6170
Device Lot Number6212647
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 11/23/2018
Supplement Date Received by Manufacturer05/06/2019
Initial Report FDA Received Date12/19/2018
Supplement Report FDA Received Date05/06/2019
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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