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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE TRIAL LEAD KIT, 60CM LENGTH; SCS LEAD
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ST. JUDE MEDICAL - NEUROMODULATION OCTRODE TRIAL LEAD KIT, 60CM LENGTH; SCS LEAD Back to Search Results
Model Number 3086
Medical Device Problem Code Patient-Device Incompatibility (2682)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/07/2019
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 underwent a trial procedure on (b)(6) 2019 that was abandoned due to patient anatomy.The patient is stable post operatively.
 
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Brand Name
OCTRODE TRIAL LEAD KIT, 60CM LENGTH
Common Device Name
SCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key8928185
Report Number1627487-2019-09662
Device Sequence Number16695890
Product Code LGW
UDI-Device Identifier05415067017222
UDI-Public05415067017222
Combination Product (Y/N)N
Initial Reporter StateNH
Initial Reporter CountryUS
PMA/510(K) Number
P010032
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/06/2019
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 Date05/21/2021
Device Model Number3086
Device Lot Number7000626
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 08/07/2019
Supplement Date Received by Manufacturer08/30/2019
Initial Report FDA Received Date08/23/2019
Supplement Report FDA Received Date09/06/2019
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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