Swift-LockRecalls & reported problems across all models
St. Jude Medical, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,635
- Deaths reported
- 0
- Injuries reported
- 1,630
- Recalls
- 0
We found 3 models of Swift-Lock by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,635 adverse event reports in the FDA's MAUDE database, received between Jun 12, 2018 and Sep 30, 2026 — classified as 1,630 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (96 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Swift-Lock problems
Device problems
- Adverse Event Without Identified Device or Use Problem1,411
- Fracture96
- Break57
- Migration33
- Material Fragmentation17
- High impedance6
- Use of Device Problem6
- Improper or Incorrect Procedure or Method5
Patient problems
- Post Operative Wound Infection532
- Unspecified Infection431
- Implant Pain227
- Inadequate Pain Relief117
- Pain80
- No Clinical Signs, Symptoms or Conditions67
- Fluid Discharge66
- Discomfort52
Swift-Lock models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Swift-Lock™ 1192STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1,400 reports
- Swift-Lock™ 1192STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)215 reports
- Swift-Lock™ 1192STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)20 reports
Recent Swift-Lock adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953872 ↗InjurySep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953855 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Implant Pain
MAUDE report 50904088 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Implant Pain
MAUDE report 50904086 ↗InjurySep 22, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861082 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50859430 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced an infection at an unknown site. As a result, surgical intervention was undertaken in (b)(6) 2023 wherein the leads and anchors were explanted to address the issue. Additionally, the IPG was explanted in (b)(6) 2024 for an unknown reason.
Patient problems: Unspecified Infection
MAUDE report 50859429 ↗OtherSep 17, 2026Fracture
Patient problems: Inadequate Pain Relief
MAUDE report 50811517 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that following significant weight loss, the patient experienced pain at the Anchor site. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the sutures on the anchors were revised, the site was irrigated and the patient was administered antibiotic to address the issue. It is unknown which Anchor the allegation is against.
Patient problems: Implant Pain
MAUDE report 50791389 ↗InjurySep 15, 2026Fracture
It was reported patient lost effective therapy and was unable to enter MRI mode due to lead and anchor fractures. The issue was confirmed via X-Rays, though investigation was unable to identify which lead and anchor they were. Surgical intervention may be pending to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50777616 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Post Operative Wound Infection
MAUDE report 50765969 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Post Operative Wound Infection
MAUDE report 50765965 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced an infection at the lead site. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the entire system was explanted to address the issue. Additionally, the patient was administered oral antibiotics to address the issue.
Patient problems: Unspecified Infection
MAUDE report 50763014 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced an infection at the lead site. As a result, surgical intervention was undertaken on (b)(6)2026 wherein the entire system was explanted to address the issue. Additionally, the patient was administered oral antibiotics to address the issue.
Patient problems: Unspecified Infection
MAUDE report 50763008 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced an infection at the IPG and lead site. As a result, surgical intervention was undertaken wherein the entire system was explanted on (b)(6)2026 to address the issue. The patient was also administered both oral and IV antibiotics to address the issue.
Patient problems: Post Operative Wound Infection
MAUDE report 50123091 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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