PROTEGE IPG, 16-CHANNEL RECHARGEABLE 3789

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 2018-12-17 for PROTEGE IPG, 16-CHANNEL RECHARGEABLE 3789 manufactured by St. Jude Medical - Neuromodulation.

Event Text Entries

[130610906] It was reported that the patient did not recharge the scs ipg per the manufacturer's recommendation. Troubleshooting was attempted, but ipg could not connect with the external devices. In turn, the ipg was inoperable. Surgical intervention may be pending to address the issue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1627487-2018-13053
MDR Report Key8172330
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2018-12-17
Date of Report2019-01-23
Date of Event2017-09-05
Date Mfgr Received2018-12-05
Device Manufacturer Date2014-06-10
Date Added to Maude2018-12-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
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 Sequence Number: 0

Brand NamePROTEGE IPG, 16-CHANNEL RECHARGEABLE
Generic NameSCS IPG
Product CodeLGW
Date Received2018-12-17
Model Number3789
Lot Number4648392
Device Expiration Date2016-06-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No0
Device Event Key0
ManufacturerST. JUDE MEDICAL - NEUROMODULATION
Manufacturer Address6901 PRESTON RD PLANO TX 75024 US 75024

Device Sequence Number: 1

Brand NamePROTEGE IPG, 16-CHANNEL RECHARGEABLE
Generic NameSCS IPG
Product CodeLSW
Date Received2018-12-17
Model Number3789
Lot Number4648392
Device Expiration Date2016-06-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 2018-12-17

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