SWIFT-LOCK ANCHOR 1192

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 2020-03-06 for SWIFT-LOCK ANCHOR 1192 manufactured by St. Jude Medical - Neuromodulation.

Event Text Entries

[182362369] During the process of complaint, attempts were made to obtain complete event information for treatment, but not available. The results/method and conclusion codes along with the investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10


[182362370] Device 4 of 5. Reference mfr. Report: 3006705815-2020-01025, 3006705815-2020-01026, 3006705815-2020-01027, 1627487-2020-02404. It was reported the patient had a suspected infection at an unknown location and the entire scs system was explanted. There was no complications observed during the procedure.
Patient Sequence No: 1, Text Type: D, B5


[186634742] A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event. Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. It was inadvertently reported the patient code as (b)(4) in initial report. The correct code has been updated.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1627487-2020-02403
MDR Report Key9799329
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-06
Date of Report2020-03-06
Date of Event2020-02-20
Date Mfgr Received2020-02-20
Device Manufacturer Date2019-06-07
Date Added to Maude2020-03-06
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 NameSWIFT-LOCK ANCHOR
Generic NameSCS ANCHOR
Product CodeGZB
Date Received2020-03-06
Model Number1192
Catalog Number1192
Lot Number7010944
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 2020-03-06

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