OCTRODE LEAD KIT, 90CM LENGTH 3189

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for OCTRODE LEAD KIT, 90CM LENGTH 3189 manufactured by St. Jude Medical - Neuromodulation.

Event Text Entries

[186068911] The event date is unknown. Concomitant medical products and therapy dates: model: 3189, scs lead, therapy date: unknown the results/method and conclusion codes along with the investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10


[186068912] Device 2 of 2. Reference mfr. Report#: 1627487-2020-03499. It was reported one of the patient's leads was found to have migrated. In turn, the lead was repositioned via surgical intervention on (b)(6) 2020 to address the issue. Note: both of the patient's leads are being reported because it's unknown which lead was repositioned
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1627487-2020-03500
MDR Report Key9908452
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-13
Device Manufacturer Date2019-03-05
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 NameOCTRODE LEAD KIT, 90CM LENGTH
Generic NameSCS LEAD
Product CodeLGW
Date Received2020-03-31
Model Number3189
Catalog Number3189
Lot Number6880060
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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