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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM DRG IMPLANTABLE PULSE GENERATOR; DRG IPG
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ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM DRG IMPLANTABLE PULSE GENERATOR; DRG IPG Back to Search Results
Model Number 3664
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 07/08/2020
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 the patient was experiencing pain at the ipg implant site.As a result, the entire ipg system was explanted on (b)(6) 2020.
 
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.
 
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Brand Name
PROCLAIM DRG IMPLANTABLE PULSE GENERATOR
Type of Device
DRG IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key10329558
MDR Text Key200594754
Report Number1627487-2020-23165
Device Sequence Number1
Product Code PMP
UDI-Device Identifier05415067020215
UDI-Public05415067020215
Combination Product (y/n)N
PMA/PMN Number
P150004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/30/2020
Device Model Number3664
Device Catalogue Number3664
Device Lot Number6477989
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/08/2020
Initial Date FDA Received07/27/2020
Supplement Dates Manufacturer Received10/14/2020
Supplement Dates FDA Received10/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight45
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