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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG
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ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG Back to Search Results
Model Number 3660
Device Problem Insufficient Information (3190)
Patient Problem Inadequate Pain Relief (2388)
Event Type  Injury  
Manufacturer Narrative
Date of event is unknown.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 received an end of service message.Therapy loss followed.As a result, the patient's ipg was explanted and replaced to address the issue.
 
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 5 ELITE IMPLANTABLE PULSE GENERATOR
Type of Device
SCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key10353561
MDR Text Key201337323
Report Number1627487-2020-23483
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05415067020192
UDI-Public05415067020192
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,health
Type of Report Initial,Followup
Report Date 10/29/2020
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? Yes
Device Operator Health Professional
Device Expiration Date08/22/2020
Device Model Number3660
Device Catalogue Number3660
Device Lot Number6600056
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/15/2020
Initial Date FDA Received07/31/2020
Supplement Dates Manufacturer Received10/15/2020
Supplement Dates FDA Received10/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight59
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