• 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 Type  Injury  
Manufacturer Narrative
The 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. The manufacturer defers to the patient's physician regarding medical history.
 
Event Description
It was reported that the patient underwent radiofrequency ablation. Approximately a week later, patient was unable to experience adequate therapy, therefore attempted to turn on the stimulation. Reportedly, the manufacturer representative attempted communicating the ipg with the external devices but to no avail. The logs are pending analysis. No further information is available at this time.
 
Event Description
Additional information identified that surgical intervention was undertaken to have the ipg explanted and replaced with another model.
 
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 Key7518848
MDR Text Key108412840
Report Number1627487-2018-04519
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,consum
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 07/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/23/2019
Device Model Number3662
Device Lot Number5911020
Other Device ID Number05415067020222
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number1627487-060217-001-C

Patient Treatment Data
Date Received: 05/16/2018 Patient Sequence Number: 1
Treatment
MODEL 1192 (2), SCS ANCHOR; MODEL 3186(2), SCS LEAD
-
-