OCTRODE LEAD KIT, 60CM LENGTH 3186

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 2018-12-20 for OCTRODE LEAD KIT, 60CM LENGTH 3186 manufactured by St. Jude Medical - Neuromodulation.

Event Text Entries

[131124477] Device 1 of 2. Reference mfr. Report#: 1627487-2018-13248. It was reported during an elective scs system upgrade procedure on (b)(6) 2018, inter-op testing revealed the patient? S leads showed impedance issues. As a result, the patient? S leads were explanted and replaced. Effective therapy was restored following the procedure and the issue is resolved.
Patient Sequence No: 1, Text Type: D, B5


[134753988] Device 1 of 2. Reference mfr. Report#: 1627487-2018-13248.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1627487-2018-13245
MDR Report Key8187444
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-12-20
Date of Report2019-02-01
Date of Event2018-11-27
Date Mfgr Received2018-11-27
Device Manufacturer Date2015-03-18
Date Added to Maude2018-12-20
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 Sequence Number: 0

Brand NameOCTRODE LEAD KIT, 60CM LENGTH
Generic NameSCS LEAD
Product CodeLGW
Date Received2018-12-20
Model Number3186
Lot Number5018286
Device Expiration Date2017-02-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 NameOCTRODE LEAD KIT, 60CM LENGTH
Generic NameSCS LEAD
Product CodeLSW
Date Received2018-12-20
Model Number3186
Lot Number5018286
Device Expiration Date2017-02-28
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 2018-12-20

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