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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/6MM, 110 CM SCS LEAD

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ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/6MM, 110 CM SCS LEAD Back to Search Results
Model Number 3151
Device Problems Disconnection (1171); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Inadequate Pain Relief (2388)
Event Date 06/29/2020
Event Type  Injury  
Manufacturer Narrative

Date of event is estimated. The results/ method and conclusion codes along with investigation results will be provided in the final report.

 
Event Description

Related manufacturer reference numbers: 1627487-2020-22844, 1627487-2020-22845. It was reported the patient experienced ineffective stimulation. During the procedure the physician noticed that the leads were not plugged in to the ipg. As a result, surgical intervention was undertaken and the leads and ipg were explanted and replaced.

 
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Brand NameQUATTRODE LEAD, 3/6MM, 110 CM
Type of DeviceSCS LEAD
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key10293546
MDR Text Key199464492
Report Number1627487-2020-22843
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/28/2011
Device MODEL Number3151
Device LOT Number2793373
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 Received07/20/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/28/2009
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: 07/19/2020 Patient Sequence Number: 1
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