• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 7 ELITE SCS IPG

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 7 ELITE SCS IPG Back to Search Results
Model Number 3662
Device Problems Temperature Problem (3022); Insufficient Information (3190)
Patient Problems No Consequences Or Impact To Patient (2199); Discomfort (2330)
Event Date 09/25/2019
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
Manufacturer report number 1627487-2019-11572. Manufacturer report number 1627487-2019-11573. It was reported that the patient is planning to have their system explanted. No additional information is available at this time.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the devices were not returned for analysis. Based on the information received, the cause of the reported event could not be conclusively determined.
 
Event Description
Additional information received identified that patient underwent surgical intervention in result of heating sensation at the ipg site. Issue has resolved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROCLAIM 7 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 Key9199916
MDR Text Key162628588
Report Number1627487-2019-11571
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
Report Date 11/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/01/2019
Device Model Number3662
Device Lot Number6185156
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 Received10/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2017
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: 10/16/2019 Patient Sequence Number: 1
-
-