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 health professional report with the FDA on 2020-03-17 for SWIFT-LOCK ANCHOR 1192 manufactured by St. Jude Medical - Neuromodulation.

Event Text Entries

[183724971] 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


[183724972] Related manufacturer reference number: 1627487-2020-02802, 1627487-2020-02804, 3006705815-2020-01208. It was reported the patient experienced pain at the anchor sites. Surgical intervention took place on (b)(6) 2020 wherein the anchors were explanted and replaced, and the leads were repositioned due to them moving during the replacement of the anchors.
Patient Sequence No: 1, Text Type: D, B5


[185627335] No implanted devices were returned for evaluation. The event information pertaining to this incident has been reviewed and no product investigation can be performed as there are no complaint allegations present nor were the circumstances of the event attributed to the implanted system.
Patient Sequence No: 1, Text Type: N, H10


[185627336] Additional information received indicates the pain has resolved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1627487-2020-02803
MDR Report Key9841952
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-17
Date of Report2020-03-30
Date of Event2020-02-24
Date Mfgr Received2020-03-17
Device Manufacturer Date2016-05-25
Date Added to Maude2020-03-17
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 Received2020-03-17
Model Number1192
Catalog Number1192
Lot Number5514919
Device Expiration Date2018-04-30
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 2020-03-17

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