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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 Date 06/26/2020
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.During processing of this complaint, attempts were made to obtain patient weight, and but it was not received.The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported the patient's ipg was unable to communicate with external devices.It is unknown if the ipg depleted prematurely.As a result, surgery occurred during which the ipg was explanted 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 Key10611010
MDR Text Key209335142
Report Number1627487-2020-31307
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,consum
Type of Report Initial,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/16/2018
Device Model Number3660
Device Catalogue Number3660
Device Lot Number5721014
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight54
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