8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B 6172

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 2020-03-26 for 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B 6172 manufactured by St. Jude Medical - Neuromodulation.

Event Text Entries

[185147507] The results/method and conclusion codes along with investigation results will be provided on the final report.
Patient Sequence No: 1, Text Type: N, H10


[185147508] It was reported that patient experienced ineffective stimulation. As a result, the left lead was explanted, and a new lead was implanted. There was no complication during the procedure. Patient was stable.
Patient Sequence No: 1, Text Type: D, B5


[185299169] New information received states that new lead implant procedure is anticipated in the near future.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1627487-2020-03299
MDR Report Key9886643
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-26
Date of Report2020-03-27
Date of Event2020-03-10
Date Mfgr Received2020-03-26
Device Manufacturer Date2018-11-29
Date Added to Maude2020-03-26
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 Name8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B
Generic NameDBS LEAD
Product CodeMHY
Date Received2020-03-26
Model Number6172
Catalog Number6172
Lot Number6742512
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 2020-03-26

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