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 2019-11-30 for PROCLAIM? 7 ELITE IMPLANTABLE PULSE GENERATOR 3662 manufactured by St. Jude Medical - Neuromodulation.

MAUDE Entry Details

Report Number1627487-2019-13366
MDR Report Key9392318
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2019-11-30
Date of Report2019-11-30
Date of Event2019-11-13
Date Mfgr Received2019-11-13
Device Manufacturer Date2017-11-09
Date Added to Maude2019-11-30
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 Number1627487/06/02/2017/001-C
Event Type3
Type of Report3

Device Details

Brand NamePROCLAIM? 7 ELITE IMPLANTABLE PULSE GENERATOR
Generic NameSCS IPG
Product CodeLGW
Date Received2019-11-30
Model Number3662
Catalog Number3662
Lot Number6197336
Device Expiration Date2019-11-09
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
101. Other 2019-11-30

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