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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 Reaction (2414)
Event Type  Injury  
Manufacturer Narrative
In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing. The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported. The manufacturer defers to the patient's physician regarding medical history.
 
Event Description
Device 2 of 2. Reference mfr. Report: 3006705815-2018-02477. The patient's wife reported the patient underwent surgical intervention to explant the system due to an allergic reaction to metal. The date of explant is unknown.
 
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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
palka sharma
6901 preston road
plano, TX 75024
9725264823
MDR Report Key7924296
MDR Text Key122293055
Report Number1627487-2018-09434
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
Report Date 10/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2017
Device Model Number3228
Device Lot Number5021776
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 Received09/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2015
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: 10/01/2018 Patient Sequence Number: 1
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