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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 PADDLE LEAD

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ST. JUDE MEDICAL - NEUROMODULATION PENTA 3MM LEAD, 60 CM SCS PADDLE LEAD Back to Search Results
Model Number 3228
Device Problem Disconnection (1171)
Patient Problem Inadequate Pain Relief (2388)
Event Date 07/24/2020
Event Type  Injury  
Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

 
Event Description

Related manufacturer report number 1627487-2020-23602. It was reported that the patient's lead had disconnected from the ipg, causing the patient to be unable to place the ipg in mri mode. In turn, surgical intervention was undertaken on an unknown date wherein the ipg was explanted and replaced, resolving the issue.

 
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Brand NamePENTA 3MM LEAD, 60 CM
Type of DeviceSCS PADDLE 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 Key10368295
MDR Text Key201716797
Report Number1627487-2020-23603
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 08/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/05/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/28/2014
Device MODEL Number3228
Device LOT Number3869132
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 Received08/27/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/26/2012
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: 08/05/2020 Patient Sequence Number: 1
Treatment
3688, SCS IPG.
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