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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 Problems Wireless Communication Problem (3283); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem Inadequate Pain Relief (2388)
Event Date 06/03/2020
Event Type  malfunction  
Manufacturer Narrative
The patient's weight was unable to be obtained.The results/method and conclusion codes along with the investigation results will be provided in the final report.
 
Event Description
It was reported the patient's ipg was initially deemed inoperable following the patient undergoing back surgery.Prior to surgery, the patient did not program their ipg into surgery mode.Troubleshooting/software update was performed later and was able to restore the patient's ipg.
 
Manufacturer Narrative
Corrected data: h6 - device code.The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.
 
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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 Key10197200
MDR Text Key196589554
Report Number1627487-2020-22179
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,health
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/04/2020
Device Model Number3664
Device Catalogue Number3664
Device Lot Number6620910
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number1627487/06/02/2017/001-C
Patient Sequence Number1
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