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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 Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Blood Loss (2597)
Date of Event 05/30/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
 
Event or Problem Description
Device 1 of 2.Reference mfr report: 1627487-2018-06096.It was reported there was bleeding at the trial lead site.As a result, the leads were explanted (b)(6) 2018.
 
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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 Key7646614
Report Number1627487-2018-06055
Device Sequence Number11151953
Product Code GZB
UDI-Device Identifier05415067017222
UDI-Public05415067017222
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
P010032
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
Report Date (Section B) 06/28/2018
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 Date11/17/2019
Device Model Number3086
Device Lot Number6201364
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 05/30/2018
Initial Report FDA Received Date06/28/2018
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;
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