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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD

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ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD Back to Search Results
Model Number 3186
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Sepsis (2067)
Event Date 03/18/2020
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with the investigation results will be provided in the final report.
 
Event Description
Device 2 of 4. Reference mfr. Report#: 3006705815-2020-01641. Reference mfr. Report#: 1627487-2020-03883. Reference mfr. Report#: 1627487-2020-03884. It was reported the patient was admitted to the hospital and sepsis was determined to be the issue that was alleged to be related to the patient's lead incision. The patient's current status is unknown at this time.
 
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Brand NameOCTRODE LEAD KIT, 60CM LENGTH
Type of DeviceSCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
lot a interior - #2 street km 67.5
santana industrial park
arecibo PR 00612
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key9955468
MDR Text Key187509164
Report Number3006705815-2020-01642
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3186
Device Catalogue Number3186
Device Lot NumberA000089316
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/07/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/13/2020 Patient Sequence Number: 1
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