SCS LEAD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for SCS LEAD manufactured by St. Jude Medical - Neuromodulation.

Event Text Entries

[186069135] Date of event is estimated. The results/method and conclusion codes along with investigation results will be provided in the final report. During processing of this complaint, attempts were made to obtain complete patient (weight), device (lead model, serial number, udi, manufacture date), and event (explant date) information. Further information was requested but not received.
Patient Sequence No: 1, Text Type: N, H10


[186069136] Related manufacturer reference number 1627487-2020-03463. It was reported that patient experienced ineffective therapy after a stroke. As a result, patient underwent surgical intervention wherein the entire scs system was explanted on unknown date.
Patient Sequence No: 1, Text Type: D, B5


[188270778] 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 Number1627487-2020-03464
MDR Report Key9908738
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2019-03-10
Date Mfgr Received2020-03-10
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 NameSCS LEAD
Generic NameSCS LEAD
Product CodeLGW
Date Received2020-03-31
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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