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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 5 ELITE SCS IPG

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ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 5 ELITE SCS IPG Back to Search Results
Model Number 3660
Device Problem Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem Inadequate Pain Relief (2388)
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with the investigation results will be provided in the final report.
 
Event Description
This report is related to a (b)(6) patient. It was reported the patient underwent shoulder surgery following a fall. Prior to the procedure the patient did not program their ipg into surgery mode. In turn, their ipg was deemed inoperable following the surgical procedure. As a result, the patient plans to undergo surgical intervention to address their inoperable ipg issue.
 
Manufacturer Narrative
The reported observation of ¿ipg communication issue¿ was confirmed. The analysis results concluded the inability to establish communication between the programmer and the implantable pulse generator (ipg) was due to the device entering the service application state. The root cause of the device entering the service application state was due to the patient¿s unrelated surgical procedure as stated in the event details. There is guidance noted in the clinicians manual concerning handling of the device: electrosurgery devices should not be used in close proximity to an implanted neurostimulation system.
 
Event Description
Additional information gathered via follow-up revealed the patient's ipg was explanted and replaced. Surgical intervention addressed the patient's issue.
 
Manufacturer Narrative
Corrected data: device available for evaluation (the return date on the previous follow-up report was deemed incorrect following further review).
 
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Brand NamePROCLAIM 5 ELITE
Type of DeviceSCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer Contact
andrea deitz
6901 preston road
plano, TX 75024
9723098000
MDR Report Key8957763
MDR Text Key156350150
Report Number1627487-2019-09958
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2020
Device Model Number3660
Device Lot Number6600182
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/29/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/03/2019 Patient Sequence Number: 1
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