EXTENSION, 30CM 3383

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for EXTENSION, 30CM 3383 manufactured by St. Jude Medical - Neuromodulation.

Event Text Entries

[186068692] Date of event is estimated. During processing of this complaint, attempts were made to obtain complete event information. 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


[186068693] Device 2 of 4. Related manufacturer reference number: 1627487-2020-03501. Related manufacturer reference number: 1627487-2020-03503. Related manufacturer reference number: 1627487-2020-03504. It was reported the patient underwent explant of scs system for unknown reason on (b)(6) 2020. Further information revealed the patient was no longer using the system, but further details were unable to be obtained.
Patient Sequence No: 1, Text Type: D, B5


[186235516] Further information revealed that the patient needed an mri and a pacemaker, making explant of the scs system elective. As the explant was elective, it does not meet reportability criteria.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1627487-2020-03502
MDR Report Key9908609
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-04-02
Date of Event2020-03-11
Date Mfgr Received2020-04-02
Device Manufacturer Date2015-09-30
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 NameEXTENSION, 30CM
Generic NameSCS EXTENSION
Product CodeGZB
Date Received2020-03-31
Model Number3383
Catalog Number3383
Lot Number5246191
Device Expiration Date2017-08-31
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 2020-03-31

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