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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PENTA 3MM LEAD, 60 CM SCS LEAD

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ST. JUDE MEDICAL - NEUROMODULATION PENTA 3MM LEAD, 60 CM SCS LEAD Back to Search Results
Model Number 3228
Device Problem High impedance
Event Date 07/04/2019
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

It was reported that diagnostic testing revealed that patient's lead has high impedance on multiple contacts. Surgical intervention may occur to address the issue.

 
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Brand NamePENTA 3MM LEAD, 60 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 Key8849211
Report Number1627487-2019-08161
Device Sequence Number1
Product CodeLGW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 07/31/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/31/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/28/2012
Device MODEL Number3228
Device LOT Number3259587
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 Received07/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/01/2010
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: 07/31/2019 Patient Sequence Number: 1
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