Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 IMPLANTABLE PULSE GENERATOR; 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 IMPLANTABLE PULSE GENERATOR; SCS IPG Back to Search Results
Model Number 3662
Device Problem Premature Elective Replacement Indicator (1483)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/07/2020
Event Type  malfunction  
Manufacturer Narrative
The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017.During processing of this complaint, attempts were made to obtain complete patient information.The results/ method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
The external device displayed early replacement indicator.Troubleshooting is pending where the software will be updated.The device is providing therapy.
 
Event Description
Additional information received indicated updating the app version cleared the error message, resolving the issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR
Type of Device
SCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key10324415
MDR Text Key200393006
Report Number1627487-2020-22987
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05415067020222
UDI-Public05415067020222
Combination Product (y/n)N
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/26/2020
Device Model Number3662
Device Catalogue Number3662
Device Lot Number6504172
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number1627487/09/12/2017/001-C
Patient Sequence Number1
-
-