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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Abscess (1690)
Event Date 07/10/2019
Event Type  Injury  
Manufacturer Narrative
Investigation results will be provided on the final report.
 
Event Description
Related manufacturer report number 1627487-2019-08353. It was reported that patient had an abscess with a bloody discharge issue. It is unknown when this issue began. Patient requested for a magnetic resonance imaging (mri) diagnosis. No further information is available.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
Related manufacturer report number 1627487-2019-08353.
 
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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 Key8818532
MDR Text Key151948153
Report Number1627487-2019-08354
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
Report Date 08/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2017
Device Model Number3228
Device Lot Number5069211
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 Received08/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/30/2015
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: 07/23/2019 Patient Sequence Number: 1
Treatment
SCS IPG
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