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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG
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ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG Back to Search Results
Model Number 3662
Device Problem Premature Elective Replacement Indicator (1483)
Patient Problem Failure of Implant (1924)
Event Date 07/20/2020
Event Type  malfunction  
Manufacturer Narrative
The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017.The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported that diagnostics indicated the elective replacement indicator (eri) triggered earlier than intended.The wireless software update was performed clearing the eri message.The device is providing therapy.
 
Manufacturer Narrative
The device was not returned for analysis; however, event details indicate that the system was updated to resolve the issue.Actions have been taken to prevent reoccurrence.
 
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Brand Name
PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR
Type of Device
SCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key10353879
MDR Text Key201359540
Report Number1627487-2020-23324
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05415067020222
UDI-Public05415067020222
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/04/2019
Device Model Number3662
Device Catalogue Number3662
Device Lot Number6210860
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number1627487/09/12/2017/001-C
Patient Sequence Number1
Patient Weight111
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