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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 07/23/2020
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 the device displayed the end of service (eos) message and it is unknown if the device depleted prematurely.Patient underwent surgical intervention on (b)(6) 2020, wherein, the ipg was explanted and replaced.Effective therapy was restored post operatively.
 
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.
 
Event Description
It was reported the device displayed the end of service (eos) message and it is unknown if the device depleted prematurely.Patient underwent surgical intervention on (b)(6) 2020, wherein, the ipg was explanted and replaced.Effective therapy was restored post operatively.
 
Manufacturer Narrative
H10 corrected data.B5: describe event or problem.D7:date of explant.
 
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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 Key10353876
MDR Text Key201329995
Report Number1627487-2020-23325
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,Followup
Report Date 10/21/2020
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? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/02/2019
Device Model Number3660
Device Catalogue Number3660
Device Lot Number6001221
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight57
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