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,consum report with the FDA on 2020-03-18 for SWIFT-LOCK ANCHOR 1192 manufactured by St. Jude Medical - Neuromodulation.

Event Text Entries

[183934276] Date of event is estimated. 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


[183934277] Related manufacturer report number: 1627487-2020-02809, 3006705815-2020-01212, 3006705815-2020-01211. It was reported that the patient had an infection at the lead site. The patient was treated with antibiotics, but the infection did not clear. As a result, surgical intervention took place wherein the entire system was explanted.
Patient Sequence No: 1, Text Type: D, B5


[188144076] As a result, a device history record was performed to review and confirm the sterility of the lead(s). Based on the documents reviewed, the source of the infection remains unknown.
Patient Sequence No: 1, Text Type: N, H10


[188916554] Additional information was received stating that the infection has resolved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1627487-2020-02810
MDR Report Key9848807
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-03-18
Date of Report2020-03-18
Date of Event2020-01-27
Date Mfgr Received2020-02-27
Device Manufacturer Date2019-01-19
Date Added to Maude2020-03-18
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 NameANCHOR
Product CodeGZB
Date Received2020-03-18
Model Number1192
Catalog Number1192
Lot Number6803434
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 2020-03-18

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