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 2020-03-31 for OCTRODE LEAD KIT, 60CM LENGTH 3186 manufactured by St. Jude Medical - Neuromodulation.

Event Text Entries

[185916157] 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 event could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10


[185916158] Related mfr reports: 1627487-2020-03494, 1627487-2020-03495 and 1627487-2020-03498. It was reported the patient's scs leads were exhibiting high impedance. Reportedly, the patient experienced a couple of falls in the past six months. Surgical intervention was taken and the patient's entire scs system was replaced and the reported issue addressed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1627487-2020-03496
MDR Report Key9908283
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-13
Date Mfgr Received2020-03-13
Device Manufacturer Date2008-11-28
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, 60CM LENGTH
Generic NameSCS LEAD
Product CodeLGW
Date Received2020-03-31
Model Number3186
Lot Number175822
Device Expiration Date2010-11-28
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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