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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 High impedance (1291)
Health Effect - Clinical Code Inadequate Pain Relief (2388)
Date of Event 10/08/2018
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
Device 2 of 2.Reference mfr report: 1627487-2018-13385.It was reported diagnostics indicated high impedance readings for both dbs leads and the left sided dbs lead was not optimally placed.Surgery was undertaken and both leads were explanted and replaced.
 
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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 Key8195894
Report Number1627487-2018-13386
Device Sequence Number11353831
Product Code MHY
UDI-Device Identifier05415067020635
UDI-Public05415067020635
Combination Product (Y/N)N
Initial Reporter CountrySW
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,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/19/2019
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? Yes
Operator of Device Health Professional
Device Expiration Date04/03/2020
Device Model Number6170
Device Catalogue Number6170
Device Lot Number6391793
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2018
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 11/27/2018
Supplement Date Received by Manufacturer11/27/2018
Initial Report FDA Received Date12/26/2018
Supplement Report FDA Received Date02/19/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
MODEL 6170, DBS LEAD
Outcome Attributed to Adverse Event Other;
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