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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 Problems Premature Discharge of Battery (1057); Use of Device Problem (1670); Temperature Problem (3022)
Patient Problem Pain (1994)
Event Date 07/31/2019
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided on the final report. Further information was requested but not received.
 
Event Description
It was reported that patient had pain and an intermittent burning sensation at the implantable pulse generator (ipg) site in her abdomen site. Patient alleged that the device came out of the ipg pocket site and that the device was not working properly. Upon diagnostic review, the ipg was determined to be inoperable due to the patient using high energy settings. A surgical intervention is anticipated in the near future. No further information is available.
 
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
New information received states that the device system was explanted. No further information was available.
 
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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 Key8949676
MDR Text Key156105710
Report Number1627487-2019-09853
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/11/2020
Device Model Number3660
Device Lot Number6263120
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/11/2018
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: 08/30/2019 Patient Sequence Number: 1
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