PRODIGY MRI IPG, 16CH, RECHARGEABLE 3772

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for PRODIGY MRI IPG, 16CH, RECHARGEABLE 3772 manufactured by St. Jude Medical - Neuromodulation.

Event Text Entries

[186018737] Date of event is estimated. During processing of this complaint, attempts were made to obtain complete event information. The results/method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10


[186018738] It was reported the patient was unable to charge the ipg just prior to a lead revision (please see reference mfr report#: 1627487-2020-02686), and ipg would not communicate with other external devices, either. Further information revealed the patient last recharged the ipg in (b)(6) 2019, and last had stimulation in (b)(6) 2019, but exact dates are unknown. To address the issue, the physician explanted and replaced the ipg with a new model, which resolved the issue.
Patient Sequence No: 1, Text Type: D, B5


[188744119] The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1627487-2020-03491
MDR Report Key9908210
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2019-11-01
Date Mfgr Received2020-03-11
Device Manufacturer Date2017-03-08
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
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRODIGY MRI IPG, 16CH, RECHARGEABLE
Generic NameSCS IPG
Product CodeLGW
Date Received2020-03-31
Model Number3772
Catalog Number3772
Lot Number5882950
Device Expiration Date2019-03-08
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 2020-03-31

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