PROCLAIM? 7 ELITE IMPLANTABLE PULSE GENERATOR 3662

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-31 for PROCLAIM? 7 ELITE IMPLANTABLE PULSE GENERATOR 3662 manufactured by St. Jude Medical - Neuromodulation.

Event Text Entries

[186390832] Date of event is estimated. The results/method and conclusion codes along with investigation results will be provided in the final report. The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017.
Patient Sequence No: 1, Text Type: N, H10


[186390833] It was reported the patient? S controller displayed the elective replacement indicator (eri) message. Troubleshooting was performed in which the app was updated, clearing the message and resolving the issue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1627487-2020-03477
MDR Report Key9908949
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-12
Date Mfgr Received2020-03-12
Device Manufacturer Date2016-12-09
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactANDREA DEITZ
Manufacturer Street6901 PRESTON ROAD
Manufacturer CityPLANO TX 75024
Manufacturer CountryUS
Manufacturer Postal75024
Manufacturer Phone9723098000
Manufacturer G1ST. JUDE MEDICAL - NEUROMODULATION
Manufacturer Street6901 PRESTON RD
Manufacturer CityPLANO TX 75024
Manufacturer CountryUS
Manufacturer Postal Code75024
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction Number1627487/09/12/2017/001-C
Event Type3
Type of Report3

Device Details

Brand NamePROCLAIM? 7 ELITE IMPLANTABLE PULSE GENERATOR
Generic NameSCS IPG
Product CodeLGW
Date Received2020-03-31
Model Number3662
Catalog Number3662
Lot Number5765846
Device Expiration Date2018-12-09
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL - NEUROMODULATION
Manufacturer Address6901 PRESTON RD PLANO TX 75024 US 75024


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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