• 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 Problem Device Inoperable (1663)
Patient Problem Inadequate Pain Relief (2388)
Event Date 05/07/2018
Event Type  malfunction  
Manufacturer Narrative
Manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported. Manufacturer defers to the patient's physician regarding medical history.
 
Event Description
It was reported the patient experienced ineffective stimulation post an unrelated scs system procedure. The patient failed to set the ipg in surgery mode. In turn, the rep was unsuccessful reprogramming the ipg. System diagnostics revealed the ipg deemed inoperable. Surgical intervention may take place at a later date to address the issue.
 
Event Description
Additional information received identified the patient underwent surgical intervention wherein the ipg was explanted and replaced. Effective therapy was achieved post operatively.
 
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
MDR Report Key7550474
MDR Text Key109493967
Report Number1627487-2018-05246
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 consumer
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2018
Device Model Number3662
Device Lot Number5432858
Other Device ID Number05415067020222
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487/06/02/2017/001-C

Patient Treatment Data
Date Received: 05/29/2018 Patient Sequence Number: 1
-
-