QUATTRODE LEAD WIDE SPACED, 60 CM 3166

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 2019-05-02 for QUATTRODE LEAD WIDE SPACED, 60 CM 3166 manufactured by St. Jude Medical - Neuromodulation.

Event Text Entries

[143841889] The results/method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10


[143841890] Device 1 of 2; reference mfr. Report#: 1627487-2019-05160. It was reported that the patient's leads migrated (confirmed via x-ray). Surgical intervention may be planned to address the issue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1627487-2019-05158
MDR Report Key8573879
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-05-02
Date of Report2019-06-10
Date of Event2019-04-17
Date Mfgr Received2019-06-03
Device Manufacturer Date2018-05-01
Date Added to Maude2019-05-02
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 NameQUATTRODE LEAD WIDE SPACED, 60 CM
Generic NamePNS LEAD
Product CodeGZF
Date Received2019-05-02
Model Number3166
Lot Number6424245
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 2019-05-02

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